Lead R&D Engineer (Medtech)

TL;DR

Lead R&D Engineer (Medtech): Leading new product development project teams to design and develop medical device solutions for ostomy care with an accent on design verification, validation, and technical leadership. Focus on 3D modeling, statistical analysis, and ensuring regulatory compliance throughout the product lifecycle.

Location: Hybrid (Must be based in Libertyville, IL, US). Sponsorship to work in the US is not available.

Salary: $110,000 - $155,000 yearly

Company

hirify.global is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.

What you will do

• Lead new product development (NPD) teams to create value-driven healthcare solutions for clinicians and end-users.
• Develop concepts, components, and systems using CAD software (Solidworks) and create detailed engineering specifications.
• Execute complex design verification and validation (V&V) protocols and perform statistical analysis on data.
• Conduct feasibility studies and risk assessments to ensure products meet performance, regulatory, and safety standards.
• Collaborate cross-functionally with marketing, operations, and quality teams to optimize designs for cost-effective manufacturing.
• Prepare technical documentation in accordance with regulatory and design control requirements.

Requirements

• Bachelor's degree in a technical discipline with 8+ years of medical device experience OR Master's degree with 6+ years.
• Must have legal authorization to work in the US (Sponsorship not available).
• Advanced proficiency in Design Controls, DHF, risk management (FMEA), and Stage Gate processes.
• Proven experience as a technical leader within multidisciplinary teams.
• Hands-on experience with prototyping and CAD modeling.
• English: C1 level (Strong verbal and written communication skills).

Culture & Benefits

• Hybrid work environment with a minimum of 4 days per week in office.
• Competitive base pay and participation in the Hollister Corporate Bonus Plan.
• Comprehensive health, prescription, dental, vision, and life insurance.
• 401(k) Retirement Savings Plan with safe harbor matching contributions.
• Paid time off including 11 paid holidays, vacation based on service, and sick days.
• Additional perks such as education and adoption assistance programs.