Sr Quality Engineer

Medtronic•North Haven, CT

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Electrical Engineering experience preferred, PCBA manufacturing/testing/designing experience preferred, supplier quality engineering experience preferred, position may be located at North Haven, CT or Lafayette, CO Careers that Change Lives A career at Medtronic is like no other. We’re committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide! Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. A Day in the Life Medtronic is currently searching for a Senior Quality Engineer to join the New Product Development team at the North Haven, CT facility or the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities.

Requirements

Bachelor’s degree in engineering or related field
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice To Haves

Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred
Medical device manufacturing industry experience, preferably ISO 13485.
Lead auditor experience.
Hands-on experience with SAP, Trackwise, Agile change management.
Ability to manage tasks and projects under tight deadlines with a sense of urgency.
Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
Engage in changes and advocate for inclusion/diversity.
Experience with materials and manufacturing processes such as PCBAs, MIM, nitinol, cables, crimping, laser welding, automated functional testing DRM or DFSS
Knowledge of GD&T

Responsibilities

Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred.
Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
Evaluate suppliers' internal functions to assess overall performance and provide feedback.
Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization).
Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
Manage the Approved Supplier List, including administrative work in MAP Agile.
Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
Improve suppliers' performance and reduce escapes to manufacturing.
Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development.
Knowledgeable in Statistical analysis (MSA, Capability, SPC)
Support DFMEA and PFMEA activities
Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
Design Transfer; translating design specifications into production specifications.
Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.
Provide mentorship and coaching.
The job requires occasional travel to visit suppliers within the United States and internationally.

Benefits

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.
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).