Sr. Sustaining R&D Engineer (Medtech)

TL;DR

Sr. Sustaining R&D Engineer (Medtech): Designing and developing innovative solutions for marketed organ preservation systems with an accent on electro-mechanical systems and product lifecycle management. Focus on enhancing existing product portfolios through design, verification, and validation in a regulated FDA environment.

Location: Boston, MA, US (Hybrid: 1-2 days at home, site-based)

Salary: $135k – $150k plus 5% STIP eligibility

Company

hirify.global (Paragonix Technologies) provides life-saving medical technology and organ preservation systems to improve clinical results worldwide.

What you will do

• Design and implement mechanical and electrical solutions for sustaining engineering initiatives.
• Collaborate with multidisciplinary teams to identify and address design improvements in existing products.
• Develop and maintain robust design specifications, 3D CAD models, and engineering drawings.
• Establish rigorous protocols to ensure design solutions meet all verification and validation requirements.
• Manage relationships with contract manufacturers and vendors to ensure project timelines are met.
• Ensure compliance with Quality Management Systems (QMS) and medical device standards.

Requirements

• Must be a US candidate.
• Minimum of 5 years of experience in medical device design and development.
• Experience in a regulated FDA/GMP environment (ISO 13485, ISO 14971).
• Proficiency in SolidWorks and experience designing for injection molding.
• Bachelor’s degree in a relevant engineering discipline.
• Willingness to travel 10-15%.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Tuition Reimbursement.
• Wellness initiatives and Health Assistance Resources.