Senior Quality Engineer
About The Position
The Peripheral Vascular Health (PVH) Operating Unit brings together a broad portfolio of peripheral vascular technologies, products, and services to address the needs of clinicians and patients worldwide. This organization partners across engineering, manufacturing, quality, and operations functions to support product performance, process excellence, and continuous improvement throughout the product lifecycle. This position is based at the Plymouth Nathan Lane facility in Plymouth, Minnesota and supports sustaining and project quality engineering initiatives across manufacturing operations. This is an onsite role with limited travel requirements. As a Senior Quality Engineer, you will serve as the quality representative for sustaining and strategic manufacturing projects supporting the Peripheral Vascular Health business. This role partners closely with cross-functional stakeholders to drive process improvements, support manufacturing excellence, ensure compliance, and provide technical leadership for quality-related project activities.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline and a minimum of 4 years of relevant experience; or an advanced degree and a minimum of 2 years of relevant experience.
- Experience supporting quality engineering activities within a regulated manufacturing environment.
- Experience analyzing technical or process data to drive investigations, root cause analysis, and corrective actions.
- Experience creating, reviewing, or approving technical documentation supporting manufacturing or quality system activities.
Nice To Haves
- Experience reviewing and approving engineering, validation, or quality documentation.
- Experience with process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Experience developing, executing, and analyzing Test Method Validations.
- Experience with risk management and validation documentation, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Master Validation Records.
- Knowledge of statistical and quality engineering tools such as Design of Experiments (DOE), Statistical Process Control (SPC), capability studies, and hypothesis testing.
- 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.
Responsibilities
- Represent Quality Engineering on manufacturing and operational improvement projects, ensuring quality requirements are integrated into project planning and execution.
- Partner with cross-functional teams to support capacity expansion, equipment replacement, technology implementation, yield improvement, and lean transformation initiatives.
- Analyze manufacturing and quality data using statistical and problem-solving methodologies to identify root causes and implement corrective actions.
- Develop and execute quality engineering deliverables, including risk assessments, qualifications, validations, and technical documentation.
- Review and approve process changes, product dispositions, corrective and preventive actions (CAPA), and other quality system documentation.
- Ensure manufacturing processes and quality activities comply with applicable regulatory, quality system, and internal requirements.
- Generate and implement solutions that improve product quality, process performance, safety, yield, cost, and cycle time.
- Provide technical guidance and mentorship to engineering and operations partners on quality engineering principles and applications.
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)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
