Neuro Device Product Development Engineer (Hybrid)

FHC Company; Maine; Hybrid; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401(k) with company match

ESOP

Job summary

FHC, Inc. Bowdoin, Maine is seeking a Product Development Engineer to join on-site, with optional hybrid work 1-2 days per week.

The role focuses on new product development and manufacturing of research and clinical devices, contributing to all stages of design, development, and support in multidisciplinary teams. Ideal candidates have 3-5 years in engineering, background in electrical, mechanical, or biomedical fields, and strong CAD, documentation, and ISO13485 experience.

Qualifications

• Bachelor's degree in electrical, mechanical, biomedical engineering or closely related field.
• 3-5 years' engineering experience; medical device industry preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience with Microsoft Office 365 suite.
• CAD software experience.
• Understanding of ISO13485:2016 and related regulations.
• Experience with engineering drawings.
• Hands-on experience with design controls, validation, and development file management.

Responsibilities

• Maintain familiarity with FHC Quality System per ISO13485:2016.
• Initiate or contribute to engineering changes (ECs), CAPAs, and bug reports as necessary.
• Contribute to development of 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, bills of materials.
• Develop production-ready processes to meet specifications.
• Manage production processes to maintain and improve performance.

Skills

Engineering experience

Medical device industry

Technical writing

Microsoft Office 365

CAD software

ISO 13485

Engineering drawings

Design controls

Design verification/validation

Education

Bachelor's degree in engineering

Associate degree considered

Tools

MS Office 365

CAD software

Job description

FHC, Inc. Bowdoin, Maine is seeking a Product Development Engineer to join on-site, with optional hybrid work 1-2 days per week.

The role focuses on new product development and manufacturing of research and clinical devices, contributing to all stages of design, development, and support in multidisciplinary teams. Ideal candidates have 3-5 years in engineering, background in electrical, mechanical, or biomedical fields, and strong CAD, documentation, and ISO13485 experience.