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Eden Prairie, Minnesota, United States
Hybrid
Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The Product Quality Engineer I provides quality engineering technical support for to the development of new medical devices and changes to existing commercialized devices. This will include development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing. The Product Quality Engineer plays an active role in the processes to ensure product changes meet quality standards consistent with ACIST Medical Systems policies, while meeting all applicable regulatory requirements. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.
Primary Duties & Responsibilities:
Global Product Quality Engineering
Provide quality support for manufacturing, inspection & test activities for products
Support product complaints investigation, analysis and final report creation
Conducts statistical analysis of product use data (complaints) and nonconformance data for the identification of trends and suggests/coordinates the implementation of necessary corrective actions.
Provide Quality Assurance support for CAPA and non-conforming material activities relating to products and process, and leading other efforts relating to quality characteristics and conformance to product requirements.
Review and approve change orders related to product/process changes, including approval of procedures and work instructions for manufacturing and inspection.
Provide direction and oversight to contract manufacturer for quality concerns, product inquiries, validations, safety, etc.
Interact with sustaining, regulatory, and operations engineering.
Design Assurance
Provide guidance and support for design verification activities. Assess and approve protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of the test specification.
Support all risk management activities from planning, analysis and verification, and risk reporting and acceptance.
Provide engineering support for testing qualifications such as UL / IEC testing, test method development, technical standards interpretation, and appropriate statistical methods, including sample size determination.
Generate the QA deliverables to meet the project scope and plan.
Supplier Quality
Participate in supplier evaluation, qualification and approval activities including audits.
Provide quality support for incoming inspection plans, procedures, and sampling methods to ensure product quality.
Assist in defining critical attributes and characteristics to be measured for components and products.
Define component qualification plans and approve first part review results.
Own and complete Supplier Corrective Action Requests (SCAR), interfacing directly with suppliers.
Oversee supplier validations, change orders, and any changes to form, fit, or function of the device.
Qualifications (Knowledge, Skills & Abilities):
Minimum
BS degree in Engineering or comparable science discipline
1-2 years work experience, which could include intern/co-op experience, in a regulated, structured environment such as medical device systems, aerospace, or automotive
Some work experience with product test, design assurance, manufacturing engineering, quality engineering, or product development
Working knowledge and experience with quality systems regulations and guidelines
Effective writing and communication skills
Preferred:
Experience creating test plans and reports
Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation
Interpersonal and communication skills to effectively translate ideas, concepts and information into actions relating to the primary duties
Ability to coordinate multiple projects simultaneously
Strong troubleshooting skills and problem-solving mindset
Medical device and manufacturing industry experience
Applied experience with statistical techniques such as reliability, gauge R&R, DOE, ANOVA, sampling plans, and SPC
Other:
Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
Estimated Starting Salary Range: $79,000 - 87,000
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.