Quality Engineer I, Manufacturing Operations
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Job Location:
North Haven, CT - USA
Monthly Salary:
$ 64800 - 97200
Posted on:
19-09-2025
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Medtronic is seeking a motivated and forward-thinking Quality Engineer with a primary focus in the areas of mechanical equipment and tooling to join the team in North Haven CT. This role is responsible for supporting manufacturing operations by ensuring quality processes and compliance with regulatory standards. The ideal candidate will have a strong foundation in mechanical engineering principles problem-solving skills and a commitment to continuous improvement. This role will support the Advanced Surgical Instruments operating unit supporting products including (but not limited to) Surgical Stapling Robotic Surgical Devices and Powered Instrumentation.
Key Responsibilities:
Support the development validation and maintenance of manufacturing equipment and tooling to meet quality and regulatory requirements.
Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances.
Collaborate with cross-functional teams including manufacturing R&D and regulatory affairs to enhance product quality and process efficiency.
Assist in designing and executing test methods for mechanical components and systems to ensure compliance with Medtronics quality standards.
Participate in risk management activities such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling.
Support equipment qualification and validation activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
Ensure adherence to FDA ISO 13485 and other relevant regulatory and quality system requirements.
Document and analyze quality data to drive process improvements and operational excellence.
Must Have: Minimum Qualifications
Bachelors Degree and 0 years of experience.
Nice to Have: Preferred Qualifications
Internship or co-op experience in a medical device pharmaceutical or manufacturing environment.
Familiarity with CAD software for tooling and equipment design.
Knowledge of Six Sigma Lean Manufacturing and process improvement methodologies.
Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
Strong analytical and problem-solving skills.
Ability to work collaboratively in a team environment.
Basic knowledge of quality systems statistical analysis and process validation.
Effective communication skills for documentation reporting and cross-functional collaboration.
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.
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.
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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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.
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
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
