Hybrid Product Development Engineer for Medical Devices

Skillcloud HCM; Bowdoin Center (ME); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health and Dental Insurance options

401K with company match

Employee Stock Ownership Plan

Generous PTO, holiday pay, paid sick时间

Job summary

FHC, Inc in Bowdoin, Maine is seeking a Product Development Engineer. You will work in a multidisciplinary environment focused on new product development and manufacturing of research and clinical devices.

The engineer contributes to all phases of product design, development, and support, with competencies in electrical, mechanical, or biomedical engineering. On-site role with opportunities for growth.

Qualifications

• Bachelor's degree in electrical, mechanical, or biomedical engineering is required; associate degree considered with demonstrated experience.
• Excellent technical writing of controlled documents (SOPs, work instructions, protocols).
• Experience with CAD software and engineering drawings is required.
• Familiarity with ISO13485:2016 and related regulations.

Responsibilities

• Maintain familiarity with FHC Quality System per ISO13485:2016.
• Initiate/contribute to engineering changes (ECs) and CAPAs 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 and reliability.

Skills

Design controls

Design verification/validation

Engineering documentation

SOP writing

CAD software

Education

Bachelor's degree in electrical, mechanical, or biomedical engineering

Associate's degree considered with experience

Tools

Microsoft Office 365

CAD software

Job description

FHC, Inc in Bowdoin, Maine is seeking a Product Development Engineer. You will work in a multidisciplinary environment focused on new product development and manufacturing of research and clinical devices.

The engineer contributes to all phases of product design, development, and support, with competencies in electrical, mechanical, or biomedical engineering. On-site role with opportunities for growth.