R&D/Released Product Engineer II

Location: Onsite in Memphis, Tennessee, United States

Salary: $88,800–$133,200 per year

Company

hirify.global develops healthcare technologies, including medical devices and connected technologies for neurological, spinal, and chronic pain conditions.

What you will do

• Support released medical devices across the commercialization-to-end-of-life product lifecycle.
• Execute sustaining engineering projects, product improvements, design changes, and manufacturing improvements.
• Develop engineering solutions using technical analysis and risk-based decision-making.
• Support design controls, including product requirements, design reviews, verification, validation, and design transfer.
• Participate in risk management, post-market investigations, quality initiatives, supplier changes, and manufacturing transfers.
• Prepare technical documentation and communicate engineering information and project status across multidisciplinary teams.

Requirements

• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering and at least 2 years of relevant experience, or an advanced degree with no required experience.
• Experience supporting products in a regulated industry.
• Knowledge of engineering fundamentals, design controls, verification and validation, and risk management principles.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not offered for this role.
• International baccalaureate degrees must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Medical device experience, especially with implantable or capital medical device technologies.
• Knowledge of FDA, ISO 13485, EU MDR, and other medical device regulations.
• Experience with sustaining engineering, post-market support, product lifecycle management, manufacturing transfers, or process validation.
• Experience with PLM systems, CAD tools, additive manufacturing, tolerance analysis, or advanced manufacturing technologies.
• Experience working in a highly matrixed organization and managing multiple priorities.

Culture & Benefits

• Full-time regular employment with health, dental, and vision insurance.
• 401(k) plan with employer contribution and match, incentive plans, paid time off, and paid holidays.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Tuition assistance or reimbursement and employee assistance resources.
• Employee Stock Purchase Plan and additional retirement benefits.