-The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for design verification and validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.
This individual will provide hands-on, technical Quality Engineering support for new and existing products including 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.
Primary Duties & Responsibilities:Design Assurance- Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) products.
- Drive the Design Control process and develop the Design and Development File (DDF) within the framework of regulatory requirements.
- Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
- Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
- Own risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
- Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
- Generate the quality assurance deliverables to meet the project scope and plan.
- Review, provide input, and approve project-related deliverables and change orders.
- Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
- Documents and reports defects found during testing and works with the development team to ensure they are resolved.
- Review Design and Development Files and Technical Files for conformance to applicable requirements.
- Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.
- Rigorous documentation for all phases of new product development including specifications, verification/validation test plans, and change orders associated with medical devices and consumable products.
- Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Maintain project plans, set/adhere to milestones, deliverables and budgets, and manage a limited number of concurrent projects.
- Ensure that all deliverables are clearly communicated to management including planning, deliverables and timing and defined objectives.
Qualifications (Knowledge, Skills & Abilities): Minimum- B.S. in Computer Science, Engineering (electrical or mechanical), or comparable science discipline
- Minimum 5 years of Quality Engineering experience in medical device industry
- Extensive knowledge of and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA)
- Extensive knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820
- Extensive knowledge of risk management and ISO14971
- Strong written and verbal communication skills to effectively translate ideas, concepts and information
- Ability to develop clear, concise, and timely oral and written reports
- Ability to support critical projects that require advanced problem solving skills and project management oversight
- Ability to travel both domestically and internationally
Preferred:- Advanced degree in Computer Science, Electrical Engineering, or Mechanical Engineering
- Quality Engineering experience with medical devices which incorporate software or products that are software as a medical device (SaMD)
- Demonstrated project management skills in order to plan, conduct and implement system assessments
Other:- Travel expected to be less than 10%.
Compensation & Total Rewards: Estimated Starting Salary Range: $112,000 - 120,000
*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.
