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Lead system-level design and risk management activities in accordance with ISO 14971
Translate customer, clinical, business, and regulatory needs into clear, verifiable system requirements
Drive technical strategy, product roadmaps, and design concepts for current and future solutions
Anticipate technical risks and lead proactive mitigation strategies
Guide cross-functional teams through complex technical challenges, design decisions, and issue resolution
Ensure adherence to FDA, ISO, and IEC design control requirements
Drive lifecycle management excellence across development and post-market phases
Influence alignment across engineering, quality, regulatory, and business functions
Serve as a technical expert and mentor, elevating team capability and performance
Contribute to intellectual property (IP) and support regulatory and audit readiness activities
Requirements
Bachelor's degree in Engineering (Mechanical, Electrical, Software, or related field)
advanced degree preferred
8+ years of engineering experience, preferably in medical devices or regulated industries
Deep knowledge of: ISO 14971 (Risk Management for Medical Devices), IEC 62304 (Medical Device Software Lifecycle), IEC/TR 80002-1 (Software Risk Management Guidance)
Proven ability to lead complex, cross-functional programs and make critical technical decisions
Strong systems thinking with the ability to solve ambiguous, high-impact problems
Demonstrated influence on technical strategy and product direction
Broad understanding of clinical, user, and business needs
Excellent communication skills with ability to tailor messaging to diverse stakeholders
Strong business acumen and ability to balance technical, financial, and timeline considerations
Recognized technical expertise and ability to mentor and develop others
Continuous improvement mindset
challenges the status quo to drive better solutions
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time
What we offer
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service