Sr. Manager, R&D

Job Responsibilities and Essential Duties

Lead the design, prototyping, and evaluation of innovative transplant devices, integrating advanced technologies to enhance organ preservation methods.

Assess potential intellectual property opportunities related to organ transplantation and preservation.

Oversee projects from concept through feasibility, verification, validation, and design transfer to manufacturing, ensuring compliance with ISO 13485 and FDA regulations.

Partner with marketing, regulatory affairs, quality assurance, and manufacturing teams to ensure regulatory compliance and commercial feasibility.

Review design outputs (e.g., schematics, CAD models, PCB layouts) and manage design controls to minimize risks (ISO 14971).

Recruit, mentor, and manage a team of high-performing engineers, fostering a culture of innovation and critical thinking.

Manage competing priorities and organizational change by clarifying tradeoffs, communicating decisions, and maintaining strong team engagement.

Oversee relationships with external vendors, consultants, and partners.

Required Knowledge & Skills

• Demonstrated basic understanding of medical device regulatory standards and frameworks, including ISO 14971 for risk management throughout the product lifecycle, IEC 62366 and FDA human factors guidance for usability engineering and use-related risk analysis, ISO 10993 for biocompatibility and biological evaluation of medical devices and materials, and IEC 60601 standards for electrical safety and essential performance of medical electrical equipment.
• Bachelor’s degree in engineering (Mechanical, Biomedical or related field). Master’s degree preferred.
• Minimum of 8 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry.
• Demonstrate understanding of design principles and requirements for injection molding and other plastic manufacturing methods.
• Demonstrated ability to lead engineering teams and direct reports through various stages of product development process
• Self-motivated with ability to think strategically and solve complex problems
• Interpersonal skills to communicate, advise, negotiate or influence others, as well as build productive working relationships in various settings.
• Previous CAD experience required. Solid Works preferred.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge

• 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

General Responsibilities

• Onsite personnel
• Must be willing to travel 15%

Pay and Schedule

• US BASED SALARY - The minimum base salary for this position is $160,000 and the maximum salary is $175,000 plus 10% in annual bonus.