Principal Systems Engineer
North Haven, CT - USA
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
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.
- 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.
- Bachelors degree with 7 years of relevant engineering experience OR Masters 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.
- 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 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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 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 findhere 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.
Required Experience:
Staff IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more