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 lmanson@fh-co.com, or 207-666-8304. We look forward to hearing from you!

Application For Employment

 

Product Development Engineer - Mechanical


The Product Development Engineer with a focus on mechanical engineering will contribute to all phases of product design, development and support. Technical competencies in the areas of mechanical engineering, biomedical engineering and micro-machining are required. Specific responsibilities will vary from project to project and shall be met by performing the following duties:

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

  • Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, root cause analysis, EC's and CAPA.
  • Deliver clear and concise communication, both written and verbal, to management, other team members and end users.
  • Assist team members in the development of design input requirements and product specifications.
  • Provide reasonably accurate estimations of the amount of work required for completion of assigned product development tasks. Alert team members as early as possible if estimates change during the development process.
  • Design novel mechanical devices based on design requirements while adhering to sound mechanical design practices.
  • Review and analyze design solutions to determine suitability for manufacture.
  • Maintain familiarity with the "state of the art" in machining and micromachining techniques, materials science, the biomedical industry, computer aided design solutions and mechanical engineering.
  • Maintain familiarity with typical operating room procedures and usability requirements for medical equipment, apply said knowledge to designs.
  • Generate procedural support documents and user manuals for developed products.
  • Provide field support, installation, and training on FHC systems and products.
  • Create 3D computer models of new product designs in support of engineering, production and marketing efforts.
  • Oversee drafting of mechanical components to ensure proper drafting and tolerancing.
  • Create verification plans and reports which leverage statistics to create dimensional confidence and tolerance intervals for new designs.
  • Maintain familiarity with regulatory and safety requirements for medical and research grade equipment.
  • Communicate with end users of designs to provide technical support and training, gather feedback, and troubleshoot problems.
  •  Create and maintain production prints, assembly instructions, bills of material, and other documentation related to developed products.
  •  Initiate and/or contribute to engineering changes (EC's), corrective and preventive actions (CAPA) and bug reports.
  • Develop and implement production ready processes to meet established specifications.
  • Seek out continuous improvement opportunities as it relates manufacturing systems, equipment, and processes.

 

COLLATERAL RESPONSIBILITIES:

  • Maintain a positive attitude and a passion for excellence in customer service and for 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.

 

SUPERVISORY RESPONSIBILITIES:

Oversee technicians and drafts-persons assisting in the development process and monitor production progress on pilot production runs of new designs.

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 or hear. The employee frequently is required to stand; walk; and use of hands and fingers, 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.

LANGUAGE SKILLS: English, additional languages beneficial

MATHEMATICAL SKILLS AND REASONING ABILITY:

Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.

CERTIFICATES, LICENSES, REGISTRATIONS: None required

EDUCATION REQUIREMENTS:

A BS degree or better in the field of Mechanical Engineering or equivalent.


Please email application materials to Lori Manson at lmanson@fh-co.com.

 

Process Engineer


The Process Engineer works closely with Production, Quality, Materials and Engineering to continually improve all manufacturing processes. This position will resolve existing production issues, identify the root cause of the problems, ensure the existing process is designed to avoid similar problems, review the existing process for improvement opportunities, revise the process to ensure efficiency, and ensure the process is accurately documented. The Process Engineer is also responsible for maintaining a high standard of excellence in all Device Master Record (DMR) documentation in support of the manufacturing process. This person must be uncompromising in his/her promotion of FHC's core values and commitment to excellence.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

  • Develop and evaluate current manufacturing practices, processes and capabilities while facilitating continual improvements through the identification of process issues/concerns.
  • Identify and implement opportunities for preventive process improvements.
  • Maintain familiarity with relevant portions of the FHC
  • Quality System and perform all duties within its guidelines, specifically those pertaining to calibration, process validation, EC's and CAPA.
  • Collaborate with the Engineering department to design, create, validate and monitor Production and Quality processes and fixturing.
  • Work closely with Production Management to gather feedback and suggestions towards continual improvements for production processes.
  • Maintain familiarity with lean manufacturing tools, statistical process control (SPC) techniques, sampling plan theory and statistical methods with an eye towards continual improvement.
  • Create, maintain and ultimately approve sampling plans for Production and incoming quality assurance through process and effectiveness audits.
  • Support the generation of metrics for the Production and Incoming Quality Assurance processes.
  • Recognize and investigate quality and service problems identified by the FHC quality system under the direction of the Quality Manager.
  • Deliver clear and concise written and verbal communication to management, other team members and end users.
  • Provide reasonably accurate estimations of the amount of work required for completion of assigned tasks.Alert team members as early as possible if estimates change during the development process.
  • Participate in product/project development activities with a focus on ensuring the manufacturability of the final design.
  • Develop and/or assist in the development of 1000 (FHC manufacturing processes), 4000 (FHC quality assurance processes) and 7000 (FHC packaging processes) level DMR assembly instructions and the fixturing and processes necessary to support them.
  • Closely monitor pilot production runs, intervening as necessary to keep builds on track and facilitate design transfer DMR review activities. Assist with the introduction of, and training for, new prints, processes and instructions.

 

COLLATERAL RESPONSIBILITIES:

  • Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
  • Enthusiastically participate in company-approved community events for the sake of charitable giving in the amount of 4 hours each quarter year.

 

SUPERVISORY RESPONSIBILITIES:

Currently there are no staff positions reporting to the Process Engineer. This position may require leadership of assigned employees in the future.

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.

JOB REQUIREMENTS:

  • Excellent verbal and written communication skills
  • Aptitude in paying close attention to detail
  • Ability to analyze issues and develop corrective and preventive actions that address the root cause
  • Ability to work with others of varied backgrounds and skill sets and assign tasks accordingly

 

EDUCATION REQUIREMENTS:

  • Bachelor's degree from an accredited technical or liberal arts institution or 1-3 years? experience in manufacturing engineering or quality assurance/control is preferred.
  • Experience in customer complaint handling; process improvement and statistical process control (SPC) is preferred.
  • Experience leading teams without direct supervisory responsibility is a plus.
  • Familiarity with ISO/FDA standards is a plus.

 

LANGUAGE SKILLS: Fluency in spoken and written English; other languages are an asset but not required

CERTIFICATES, LICENSES, REGISTRATIONS:

  • Certified Quality Engineer (CQE) a plus
  • Lean or Six Sigma green belt a plus


Please email application materials to Lori Manson at lmanson@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