Careers

Thank you for your interest in a career at FHC! As resumes don't always provide the information we desire from applicants, we ask that, in addition to your resume, you also send a completed application. Click the link below to download an application. You will need Adobe Acrobat Reader to open this file. Please e-mail or fax your completed application to mcooper@fh-co.com, or 207-666-8304. We look forward to hearing from you!

Application for Employment

Global Representation Specialist

FHC is seeking a Global Representation Specialist. The successful candidate will be responsible for assuring appropriate FHC registration for distribution in markets throughout the world. The Global Representation Specialist will partner with sales and marketing to develop and maintain appropriate registrations to meet FHC’s goals. Activities will include research and evaluation of opportunities and communication of market requirements for registration and distribution of FHC products, both directly and through our largest partner, Medtronic. This position will provide and generate documentation and other activities needed to maintain FHC’s compliance with all local, regional, national and international regulatory laws, standards and regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
(Other duties may be assigned)

  • Be familiar with FDA and global medical device regulatory requirements.
  • Stay abreast of new and changed regulations and communicate such to department managers for potential implementation actions required.
  • Participate in continued regulatory industry training and apply concepts to FHC processes.
  • Research and communicate regulatory requirements for new market consideration.
  • Assemble and submit establishment and product license applications in identified markets.
  • Assist in contracting with Authorized Representatives, Market Authorization Holders and Notified Bodies and ensuring they meet duties outlined in signed agreements.
  • Create, maintain and, as necessary, acquire legalization of documents required for registration such as the Certificate to Foreign Governments, Declarations of Compliance and Letters of Authorization.
  • Maintain establishment and product licenses that require periodic renewal.
  • Maintain and communicate product registration charts to internal customers.
  • Partner with project team members to ensure regulatory requirements are met throughout the product development process and that any considerations have been made for the various identified markets.
  • Research clearance requirements for investigational and custom devices and, as necessary, special access for medical devices that have yet to be cleared.
  • Review and approve marketing, advertising, sales and promotional materials and activities to ensure they adhere to regulatory requirements in identified markets.
  • Review and approve labeling to ensure it adheres to regulatory requirements in identified markets.
  • Review import and export processes to ensure they adhere to regulatory requirements in identified markets.
  • Responsible for Postmarket Surveillance activities in identified markets to include complaints, adverse events, recalls and withdrawals.
  • Partner with internal departments to ensure device development documentation such as risk assessments, compendiums of standards and technical files are accurate and up-to-date.
  • Partner with the Quality Systems Officer in the execution of the Quality Management System, development of internal audits and preparation for and response to external audits.
  • Develop and maintain open regulatory Original Equipment Manufacturer (OEM) communication with Medtronic and assist in OEM product registration globally.
  • Administrative support to VP Customer Collaboration as requested.

COLLATERAL RESPONSIBILITIES:

  • Maintain a positive attitude and a passion for excellence in customer service and promoting the well-being of the company, its products and its employees.
  • Enthusiastically participate in company-sponsored community events for the sake of charitable giving in the amount of 4 hours each quarter year.
  • Position requires willingness to work a demanding, flexible schedule with frequent extra effort and occasional business travel.

Established office work hours will be necessary but consideration will be made for the nature of international business and those commitments outside of local time.

SUPERVISORY RESPONSIBILITIES:

  • None at this time.

QUALIFICATIONS:

  • Self-motivated individual who embraces new or challenging experiences.
  • Be highly organized, detail-oriented and able to maintain organized electronic and paper files and records.
  • Proficient in office computer systems with particular experience in Word, Excel and PowerPoint.
  • Possess advanced oral and written communication skills and the ability to partner effectively with internal departments.
  • Ability to work with a minimum of supervision.
  • Ability to think in long-range terms.
  • Ability to integrate seemingly disparate concepts and rationales.
  • Ability to work with others of varied backgrounds, cultures, countries and skill sets.

 

EDUCATION and/or EXPERIENCE:

Bachelor’s degree from an accredited technical or liberal arts institution or the equivalent in experience (three years) in either quality and/or regulatory affairs OR technical/engineering experience.

LANGUAGE SKILLS:

  • English as primary language
  • Foreign language skills helpful but not required

MATHEMATICAL SKILLS:

  • Not applicable.

REASONING ABILITY:

The ability to assimilate, analyze and respond to the varied, complex and frequently conflicting quality and regulatory obligations.

CERTIFICATES, LICENSES, REGISTRATIONS:

Although not strictly required, any quality and/or regulatory certifications from recognized bodies will be regarded as valuable assets.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand, walk and use hands and fingers to handle or feel. The employee is occasionally required to sit, reach with hands and arms, stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate.

 

Product Innovation Intern

FHC is seeking a Product Innovation Intern to support the Customer Collaboration team in day-to-day functions of product development and customer support. This work will include supporting new and existing products in stereotactic and electrophysiology for neurosurgical and neuroscience advancement.


Proposed work includes:

1. Risk analysis of new products planned for market release.

2. Support ongoing innovation projects includuding utilizing skills in modeling, documentation, testing and other technical skills.

3. Support creation of product technical files to meet ISO requirements and quality standards

4. Work with the engineering and innovations departments to review, prepare and respond to product development requests as they apply to clinical and basic science products.

5. Support new product design transfer initiatives including document preparation.

6. Support as needed various other tasks including device testing, validation, verification.


Learning Opportunities:

1. Develop an understanding of the product development cycle for medical devices.

2. Put skills to use in a real-world application of bringing medical and basic sciemce devices to market.

3. Develop skills in interdepartmental work including Innovations, Quality, Operations, Marketing, Sales and Regulatory

4. Gain an understanding of global business and its structure and opportunities.


Internship Requirements:

1. Intern will be enrolled in or have completed a baccalaureate or masters program with a major appropriate to bioengineering, mechanical engineering and business work.

2. Each day intern will update a log of work completed. Be sure to record work experiences and lessons learned. Log template will be provided. At end of week, email weekly log to supervisor.

3. Intern will build a portfolio of projects and an outline of new job experiences gained during internship.

4. Proof of Maine residency

Please email application materials to Bryan Briggs, Vice President Customer Collaboration- bbriggs@fh-co.com.

 

Product Launch Intern

FHC is seeking a Product Launch Intern to support the Customer Collaboration team in day-to-day functions of product development and customer support. This work will include supporting new and existing products in stereotactic and electrophysiology for neurosurgical and neuroscience advancement.


Proposed work includes:

1. Review of Device Master Records of new products planned for market release.

2. Support ongoing innovation product launch efforts and utilize skills in , documentation, field validation and other technical skills.

3. Support creation of product marketing technical resources to meet sales and marketing standards.

4. Work with the Innovation department to review, prepare and respond to product field action requests as it applies to clinical and basic science products.

5. Support new product design transfer initiatives including document preparation.

6. Support as needed various other tasks including document review and submission to controlled technical file and reporting authorities.


Learning Opportunities:

1. Develop an understanding of the product development cycle for a medical device company.

2. Put skills to use in a real-world application of bringing medical and research devices to market.

3. Develop skills in interdepartmental work including Innovations, Quality, Operations, Marketing, Sales and Regulatory

4. Gain an understanding of global business and its structure and opportunities.


Internship Requirements:

1. Intern will be enrolled in or completed a baccalaureate or masters program with major appropriate to bioengineering or mechanical engineering and or masters n business administration.

2. Each day intern will update a log of work completed. Be sure to record work experiences and lessons learned. Log template will be provided. At end of week, email weekly log to supervisor.

3. Intern will build a portfolio of projects and an outline of new job experiences gained during internship.

4. Proof of Maine residency

Please email application materials to Bryan Briggs, Vice President Customer Collaboration- bbriggs@fh-co.com.


Regulatory Intern

FHC is seeking a Regulatory Intern to support the Customer Collaboration team in day-to-day functions of product development and customer support. This work will include supporting new and existing products in stereotactic and electrophysiology for neurosurgical and neuroscience advancement.


Proposed work includes:

1. Risk analysis of new products planned for market release.

2. Support ongoing innovation projects and utilizing skills in modeling, documentation, testing and other technical skills.

3. Support creation of product labeling to meet regulatory and quality standards

4. Work with the regulatory department to review, prepare and respond to product registration requests as it applies to clinical products.

5. Support new product design transfer initiatives including document preparation.

6. Support as needed various other tasks including document review and submission to foreign governments and global partner offices.


Learning Opportunities:

1. Develop an understanding of the product development cycle for a medical device company.

2. Put skills to use in a real-world application of bringing medical and research devices to market.

3. Develop skills in interdepartmental work including Innovations, Quality, Operations, Marketing, Sales and Regulatory

4. Gain an understanding of global business and its structure and opportunities.


Internship Requirements:

1. Intern will be enrolled in or completed a baccalaureate or masters program with major appropriate to bioengineering or mechanical engineering and business work.

2. Each day intern will update a log of work completed. Be sure to record work experiences and lessons learned. Log template will be provided. At end of week, email weekly log to supervisor.

3. Intern will build a portfolio of projects and an outline of new job experiences gained during internship.

4. Proof of Maine Residency

Please email application materials to Bryan Briggs, Vice President Customer Collaboration- bbriggs@fh-co.com.


Innovation and Development Manager

FHC is seeking an Innovation and Development Manager, that will be intimately involved in all aspects of technology and product development, supported through internal and external funding, as well early product commercialization.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

  • Desire to maintain a broad knowledge of and implement state-of-the art technology in the area of electrodes and instrumentation for clinical and research electrophysiology, as well as for stereotactic positioning devices.
  • Support FHC’s product strategy to achieve aggressive growth in research and clinical micro - recording and stimulation devices.
  • Design, develop and bring to market technologies and devices that help in curing or improving the quality of life of the patients.
  • Ability to develop and sustain a strong grant program (SBIR, STTR or similar), in collaboration with partners from renowned academic and medical institutions. Must qualify as principal investigator, support authoring and manage grant application submission and reporting; monitor and oversee progress to grants awarded.
  • Maintain active corporate status with government agencies to qualify for participation in federal grant opportunities.


COLLATERAL RESPONSIBILITIES:

  • Capacity to coordinate multi-disciplinary teams in an industry-specific environment.
  • Maintain a positive attitude and a passion for excellence in customer collaboration and for promoting the well-being of the company, its products and its employees.


QUALIFICATIONS:

  • Candidates should have a PhD in Biomedical Engineering, Neuroscience, or related discipline
  • At least 3-5 years of experience in neuroscience, medical or related research, in an industrial or academic environment.
  • Proven track record of the ability to act as a principal investigator for various US or international grant programs.
  • Excellent writing and communication skills
  • Excellent project management and organization skills
  • Scientific mind, thought, and documentation process
  • Exhibits knowledge of and clearly communicates the management of time and resources
  • Demonstrates supervisory skills- coaching, mentoring and performance evaluation
  • Demonstrates leadership qualities
  • Ability to evaluate resource needs and availability
  • Ability to think in long range terms


EDUCATION and/or EXPERIENCE:

PhD in biomedical engineering, neuroscience, nanotechnology, physics or related.

LANGUAGE SKILLS:
Fluent written and verbal English; additional languages are beneficial however not required.

MATHEMATICAL SKILLS:
Excellent mathematical skills

REASONING ABILITY:
Logical deductive reasoning

CERTIFICATES, LICENSES, REGISTRATIONS:
None required at this time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand; walk; and use hands and fingers to handle or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate.

Please email application materials to HR@fh-co.com.

 

Scientist, Nanotechnology for Electrophysiological Sensors

FHC is seeking an industrial research scientist to work for the applications of nanotechnology for the development of the next-generation electrophysiological sensors, chiefly for extracellular recording of bioelectric signals, as well as electrical stimulation. Focus will be on translational research that based on innovative technologies, creates and brings to market advanced devices to be used in healthcare, as well as in clinical and basic research.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

  • Desire to maintain a broad knowledge of and implement state-of-the art technology in the area of nanotechnologies, electrochemistry, sensors, devices and instrumentation for electrophysiological signal recording and stimulation.
  • Design, develop and bring to market technologies and devices that help in curing or improving the quality of life of the patients.
  • Maintain and develop the technology used for manufacturing current range of single and array electrodes for clinical and research electrophysiology.
  • Collaborate with customers and partners from renowned academic and medical institutions to innovate or introduce new technologies and devices.
  • Collaborate with field-support employees to bridge the research with the day-to-day use of FHC technology.
  • Work with I&D manager and CTO to clearly define research priorities and apply for internal and external funding (including SBIR, STTR or similar grant programs) to support the plans.
  • Must qualify as investigator for US-government grant programs, support authoring and manage grant application submission and reporting; monitor and oversee progress to grants awarded.
  • Realistically estimates of the effort required to complete projects. Focus on keeping research/technology projects on track. Provide accurate internal and external progress reports and status updates to the management.
  • Collaborate with other departments within the company to maintain a sense of the effort required to bring products to market, including testing and regulatory requirements for medical devices, in particular.


COLLATERAL RESPONSIBILITIES:

  • Capacity to work in a multi-disciplinary, industry-specific environment.
  • Maintain a positive attitude and a passion for excellence in customer collaboration and for promoting the well-being of the company, its products and its employees.
  • Community awareness, participate in company-sponsored community events.


QUALIFICATIONS:

  • Candidates should have a PhD in Biomedical Engineering, Nanotechnology, Neuroscience, Physics, Material Science, or related discipline
  • At least 1 year of experience in neuroscience, medical or related research, in an industrial or academic environment.
  • Previous participation as principal investigator, co-investigator or key person in academic or industrial grant programs is a plus.
  • Excellent writing and communication skills
  • Excellent project management and organization skills
  • Ability to use data analysis, modelling and scientific programming environments such as Matlab or Python. Basic knowledge of a general-purpose programming language (C++, C#, Java) is a plus.
  • Ability to coordinate and supervise technicians and other staff supporting the ongoing projects.


EDUCATION and/or EXPERIENCE:

PhD in biomedical engineering, neuroscience, nanotechnology, physics or related.

LANGUAGE SKILLS:
Fluent written and verbal English; additional languages are beneficial however not required.

MATHEMATICAL SKILLS:
Excellent mathematical skills

REASONING ABILITY:
Logical deductive reasoning

CERTIFICATES, LICENSES, REGISTRATIONS:
None required at this time.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand; walk; and use hands and fingers to handle or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate.

Please email application materials to HR@fh-co.com.

·         Assist Regulatory Affairs Associate with recall notifications and incident reporting, including generation of customer notification, customer contact lists, follow-up notifications and reporting to regulatory bodies. 

·         Provide documents to distributor and regulatory agencies for registration of products worldwide.

·         Prepare documents for legalization/apostille; corresponds with consulates or other agencies.

·         Prepare and maintain priority lists for pending registrations, updates progress and communicates delays.  Submits report to QSO & Quality & Regulatory Affairs Manager on a monthly basis.

·         Provide documents to distributor and regulatory agencies for registration of products worldwide

·         Audit completed ECs weekly so as to provide input to the QEST for the weekly RC meeting preparation.

·         Monitor emails received through FHC’s quality email address and open RNs when necessary and/or forward the email to the appropriate individual if not a customer complaint (e.g. request for quotation, request for technical assistance etc.)

·         Assist the Regulatory Affairs Associate in the review & approval of routine sterilization load documentation for the release and validation of sterile product.

·         Assist in the review, preparation, and maintenance of regulatory documents in support of project development of new products and maintenance of existing products.

·         Assist the Regulatory Affairs Associate in the preparation, review, and revision of protocols, final reports, standard operating procedures, forms, manuals, technical files, and marketing materials.

·         Primarily responsible for the submittal and maintenance of FHC’s FDA Establishment Registration, Small Business Designation renewal, Certificates to Foreign Government (CFGs), MDD Product Lists for the EU, Medical Device Listing spreadsheet.

·         Assist QSO in the preparation of responses to external audit findings.

·         Act as an internal auditor and assist QSO in preparation and organization of internal audit documentation before, during and upon conclusion of the audit annually.

·         Assist in the revision of existing and new quality documents.

·         Must be familiar with FHC’s CAPA software application and the rules for its use and assist employees with CAPA processes (RNs, NCs, ECOs, etc) and other issues related to the Quality Management System.

Actively participate in and set an example for other employees regarding maintenance of an overall company-wide quality ethic program, by ensuring other departments have the necessary information to export product in compliance with regulatory protocols