Getinge · 4 hours ago
Sr Product Development Engineer
North Waltham, MA, US
Full-time
Onsite
Senior Level
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. As a Senior Product Development Engineer, you will be responsible for designing and developing innovative solutions for next-generation organ preservation systems, collaborating with specialized teams to enhance the existing product portfolio and drive pipeline advancement.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Design and implement mechanical and electrical solutions to advance new product development initiatives
Collaborate with multidisciplinary teams to interpret customer requirements and translate them into clear technical specifications
Evaluate design solutions utilizing both experimental methods and analytical techniques
Research and assess emerging technologies and components to identify opportunities for product innovation and enhancement
Develop and maintain thorough design specifications, 3D CAD models, engineering drawings, and related documentation
Prepare and deliver engineering documentation, ensuring effective communication of results to technical teams, manufacturing partners, and Paragonix leadership
Establish rigorous evaluation protocols to confirm that design solutions meet all verification and validation requirements
Ensure that all design and development activities adhere to the company’s Quality Management System (QMS) and comply with applicable medical device standards
Qualification
Required
Experience in a regulated FDA/GMP environment, with strong understanding of quality systems (ISO 13485) and risk management (ISO 14971)
Demonstrated experience in the design, development, and successful commercialization medical devices from concept to launch in compliance with 60601-1
Proven ability to create robust, manufacturable, and practical design solutions for complex challenges
Track record of leading products through the concept phase to manufacturing transfer
Excellent communication, collaboration, problem-solving, root cause analysis, and critical thinking skills
Minimum of 5 years' experience in medical device design and development
Highly self-motivated, with a passion for addressing complex problems
Proficiency in SolidWorks is required
Competence in designing for injection molding
Bachelor's degree in a relevant engineering discipline is required
Preferred
An advanced degree is preferred
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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