Principal Systems Engineer

BioCT Innovation Commons; North Haven (CT); On-site; USD 134,000 - 202,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) plan with employer match

Paid time off

Short-term incentive opportunities

Job summary

Medtronic in North Haven, CT is seeking a Principal Systems Engineer to lead systems engineering across wound management and hernia product families. You will drive requirements, risk management, verification, validation, and lifecycle activities while collaborating with R&D, Quality, Regulatory, Manufacturing, Marketing, and Released Product Engineering teams.

The role emphasizes technical leadership, cross-functional collaboration, and MBSE best practices to ensure product performance,

Qualifications

• Experience in regulated medical device development.
• Knowledge of design controls and product lifecycle processes.
• Experience leading cross-functional projects.
• Ability to work onsite in North Haven, CT.

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.

Skills

Systems engineering

Requirements management

Risk management

Verification & Validation

Design controls

Cross-functional collaboration

Leadership

Mentoring

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Model-based systems engineering

Requirements traceability

Job description

We anticipate the application window for this opening will close on - 12 Sep 2026

A Day in the Life

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.

Primary 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise‑wide workforce planning approach, U.S. work authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): $134,400.00 - $201,600.00 This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well‑being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.