Product Development Engineer – Medical Devices (Onsite)

KMA Human Resources Consulting; Greenville (PA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health & Dental Insurance

401K with company match

Employee Stock Ownership Plan

Professional development stipend

Life Insurance

HSA and DCA accounts

Job summary

FHC, Inc. is seeking a Product Development Engineer to join the Greenville, PA team for new product development and manufacturing of research and clinical devices. You will contribute to all phases of design, development and support in a multi-disciplinary environment.

The role requires mechanical or biomedical engineering expertise and hands-on involvement with design controls, verification/validation, and document management in ISO 13485 settings.

Qualifications

• Bachelor’s degree in mechanical, or biomedical engineering, or closely related field; an associate’s degree considered with experience.
• 3–5 years’ engineering experience; medical device industry preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience with Microsoft Office 365 suite.
• Demonstrated experience with CAD software.

Responsibilities

• Maintain familiarity with ISO 13485:2016 Quality System.
• Initiate engineering changes, CAPAs, and bug reports as needed.
• Develop design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions for suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, and BOMs.
• Develop production-ready processes to meet specs.
• Manage production processes to improve performance and reliability.

Skills

Mechanical engineering

Biomedical engineering

Technical writing

CAD software

Microsoft Office 365

Design controls

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in biomedical engineering

Associate’s degree with relevant experience

Tools

CAD software

Job description

FHC, Inc. is seeking a Product Development Engineer to join the Greenville, PA team for new product development and manufacturing of research and clinical devices. You will contribute to all phases of design, development and support in a multi-disciplinary environment.

The role requires mechanical or biomedical engineering expertise and hands-on involvement with design controls, verification/validation, and document management in ISO 13485 settings.