Principal Systems Engineer
About The Position
The Surgical Operating Unit develops products used across a broad range of surgical procedures, including wound management and hernia repair. This role supports a large, globally launched portfolio of sutures, needles, meshes, and related wound closure technologies with an emphasis on systems engineering excellence across the product lifecycle. The portfolio includes thousands of commercially available product configurations and requires close collaboration across Research and Development, Quality, Regulatory, Marketing, Manufacturing, and Released Product Engineering teams to ensure continued product performance, compliance, and business continuity. This position is based in North Haven, Connecticut and requires an onsite work arrangement. Limited travel may be required to support business needs, product evaluations, manufacturing activities, or cross-functional collaboration. As a Principal Systems Engineer, you will provide technical leadership for systems engineering activities supporting launched and incrementally developing wound management and hernia products. This role serves as a key systems engineering subject matter expert, driving requirements definition, risk management, design change assessments, technical investigations, and traceability activities across complex, high-volume product families. The position partners closely with cross-functional stakeholders to evaluate product impacts, enable informed technical decisions, and establish systems engineering best practices for the portfolio.
Requirements
- Bachelor's degree with 7+ years of relevant engineering experience, OR Master's degree with 5+ years of relevant engineering experience, OR PhD with 3+ years of relevant engineering experience.
- Experience performing systems engineering activities within a regulated product development environment, including requirements management, risk management, verification, and validation.
- Experience supporting design controls and product lifecycle activities for commercialized products.
- Experience leading technical projects and influencing cross-functional stakeholders.
- Ability to work onsite in North Haven, Connecticut.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Degree in Systems Engineering, Biomedical Engineering, Materials Science Engineering, Mechanical Engineering, or a related engineering discipline.
- Experience within the medical device industry supporting wound management, sutures, needles, mesh, consumable products, or similar product portfolios.
- Experience supporting high-volume product families with a large number of product configurations, stock keeping units (SKUs), or variants.
- Experience with systems engineering tools and methodologies, including requirements traceability, risk analysis, and model-based systems engineering.
- Experience supporting released products through design changes, product improvements, technical investigations, and manufacturing or quality-driven initiatives.
Responsibilities
- Lead systems engineering activities across wound management and hernia product families, including requirements management, risk management, verification and validation planning, and lifecycle support.
- Establish and maintain intended use definitions, use cases, use conditions, stakeholder needs, design inputs, and end-to-end traceability across product and system requirements.
- Assess the impact of design, process, material, manufacturing, and labeling changes on launched products and product families.
- Drive technical investigations, root cause analyses, and cross-functional problem-solving activities to support product performance, quality, and regulatory compliance.
- Evaluate system-level risks, tradeoffs, and design decisions to ensure alignment with customer needs, product requirements, manufacturing feasibility, and business objectives.
- Apply systems engineering methodologies and best practices to improve consistency, efficiency, and technical rigor across the portfolio.
- Partner with Research and Development, Quality, Regulatory Affairs, Manufacturing, Marketing, and Released Product Engineering teams throughout the product lifecycle.
- Mentor and provide technical guidance to engineers and cross-functional team members on systems engineering processes, tools, and deliverables.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
