Product Quality Engineer - Bracco Medical Technologies

Product Quality Engineer I

Provides quality engineering technical support for 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 role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.

• Provide quality support for manufacturing, inspection & test activities for products
• Support product complaints investigation, analysis and final report creation
• Conduct statistical analysis of product use data and nonconformance data for trend identification and coordinate corrective actions
• Provide Quality Assurance support for CAPA and non-conforming material activities and lead other quality initiatives
• Review and approve change orders related to product/process changes, including procedures and work instructions
• Provide direction and oversight to contract manufacturers for quality concerns, product inquiries, validations, safety, etc.
• Interact with sustaining, regulatory and operations engineering

• Provide guidance for design verification activities
• Assess and approve protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and test specification quality
• Support all risk management activities from planning, analysis, verification, reporting and acceptance
• Provide engineering support for testing qualifications such as UL/IEC testing, test method development, standards interpretation and statistical methods including sample size determination
• Generate QA deliverables to meet project scope and plan

• Participate in supplier evaluation, qualification and approval activities including audits
• Provide quality support for incoming inspection plans, procedures and sampling methods
• Assist in defining critical attributes 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 changes to form, fit or function of the device

• Minimum BS degree in Engineering or comparable science discipline
• 1–2 years work experience, including intern/co‑op experience, in a regulated, structured environment such as medical device, aerospace or automotive
• Experience with product test, design assurance, manufacturing engineering, quality engineering or product development
• Working knowledge of quality systems regulations and guidelines
• Effective writing and communication skills
• Preferred:
  Experience creating test plans and reports
• Working knowledge of FDA Quality System Regulation, ISO 13485, and Medical Device Regulation
• Strong interpersonal and communication skills to translate ideas into actions
• Ability to coordinate multiple projects simultaneously
• Strong troubleshooting and problem‑solving mindset
• Experience with statistical techniques such as reliability, gauge R&R, DOE, ANOVA, sampling plans, and SPC
• Detail oriented with ability to manage multiple priorities in a deadline‑sensitive environment

Estimated Starting Salary Range: $79,000 - $87,000

• Total Rewards:
  Paid Time Off, Company Holidays & Paid Family Leave, 401(k) savings plan contributions, annual incentive plan
• Live Well: medical, dental, vision, life insurance, employer HSA contributions, employee assistance program, short‑term disability
• Evolve: structured on‑the‑job learning, workshops, seminars, tuition reimbursement
• Choose: flexible hybrid or in‑office arrangements, business casual attire, schedule flexibility where possible

Bracco Medical Technologies is an affirmative action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings. If you need accommodations during the application and interview process, please contact us.