Product Development Engineer-ME (Medical Devices)

Location: On-site in Bowdoin, Maine, United States; flexible schedule with an opportunity to work remotely 1–2 days per week.

Salary: $75,000–$85,000 per year

Company

hirify.global designs, manufactures, and internationally markets customizable research and clinical devices for neuroscientists, neurologists, and neurosurgeons.

What you will do

• Contribute to all phases of new product design, development, manufacturing, and product support.
• Develop design input requirements, product specifications, novel designs, and design solutions.
• Create prototypes, testing and verification plans, production prints, assembly instructions, and bills of material.
• Develop production-ready processes that meet established specifications.
• Initiate and contribute to engineering changes, corrective and preventive actions, and bug reports.
• Manage production processes to improve performance and reliability.

Requirements

• Bachelor’s degree in electrical, mechanical, or biomedical engineering, or a closely related field; an associate’s degree may be considered with demonstrated experience.
• 3–5 years of engineering experience; medical device experience is preferred.
• Experience with CAD software, engineering drawings, and Microsoft Office 365.
• Excellent technical writing skills for controlled documents, including SOPs, work instructions, and protocols.
• Understanding of ISO 13485:2016 and related regulations.
• Hands-on experience with design controls, design verification and validation, and design and development file management.

Nice to have

• Experience in the medical device industry.

Culture & Benefits

• Health and dental insurance options, with life insurance also available.
• 401(k) with company match and an Employee Stock Ownership Plan.
• Generous paid time off, holiday pay, and paid sick time.
• Up to $1,000 per year for approved professional development.
• HSA and DCA accounts, onsite childcare discounts, and an onsite fitness center with recreational facilities.