SUMMARY: The Product Development Engineer will work in a multi-disciplinary environment with a focus on new product development and manufacturing of research and clinical devices. The engineer contributes to all phases of product design, development, and support. Technical competencies in the areas of mechanical or biomedical engineering are required. Specific responsibilities will vary from project to project and shall be met by performing the following duties:
WORK LOCATION:
This is a full-time, on-site position based at FHC’s facility in Bowdoin, ME or Greenville, PA. Regular physical presence is required to support hands-on prototyping and manufacturing activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.
- Operate within and actively support FHC's Quality Management System in accordance with ISO 13485:2016.
- Initiate, author, and/or contribute to Engineering Changes (ECs) and Corrective and Preventive Actions (CAPAs) as required; ensure timely closure in the quality management system.
- Maintain and contribute to design and development files throughout the product development lifecycle, ensuring records are complete and current.
- Create, revise, and maintain controlled documents including production prints, assembly instructions, bills of materials (BOMs), work instructions, and medical device files.
- Originate novel device designs and solutions based on defined design inputs, ensuring compliance with applicable standards and regulations and adherence to sound engineering and safety principles.
- Assist in the development, review, and approval of design input requirements and product specifications, ensuring traceability from inputs through outputs, verification, and validation.
- Review and analyze design solutions for suitability, functionality, manufacturability, and regulatory compliance; participate in design reviews.
- Create and evaluate prototypes to test, verify, and iteratively refine new designs prior to formal design freeze.
- Apply risk management principles in accordance with ISO 14971 throughout the product development process, including hazard identification, risk estimation, risk evaluation, and risk control measures; maintain or contribute to risk management files.
- Author and execute product verification and validation (V&V) plans.
- Develop and validate production-ready processes and process controls to meet established device specifications, support process transfer to manufacturing.
- Maintain process validation documentation including Installation (IQ), Operational (OQ), and Performance Qualifications (PQ) where applicable.
- Develop and maintain software validation documentation for engineering tools and software used in product development or production.
- Perform and support investigations into product complaints, field failures, and adverse events; prepare investigation summaries and contribute to MDR/vigilance reporting determinations as directed.
- Monitor and improve production process performance and reliability; apply statistical methods as appropriate.
- Participate in internal and external quality audits as required; provide objective evidence and support timely resolution of audit observations.
- Communicate clearly and concisely, both written and verbally, with management, cross-functional team members, contract manufacturers, suppliers, and end users.
- Provide reasonably accurate task effort estimates; communicate scope or timeline changes to the team as early as possible.
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 or other community events for the sake of charitable giving in the amount of 4 hours each quarter year.
QUALIFICATIONS:
- Excellent verbal and written communication skills, including technical writing of controlled documents (SOPs, work instructions, protocols, reports).
- Strong attention to detail and commitment to documentation accuracy within a regulated quality system environment.
- Ability to work collaboratively with cross-functional teams of varied backgrounds and skill sets.
- Demonstrated understanding of, or aptitude to learn, ISO 13485:2016 and related regulations.
- Familiarity with risk management principles (ISO 14971) is a plus.
- Familiarity with manufacturing engineering, GMP environments, or chemical safety is a plus.
- Familiarity with FDA regulatory submission processes (e.g., 510(k), De Novo) or EU MDR technical documentation is a plus.
Job Type: Full-time
Pay: $75,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
