Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Principal Design Quality Assurance Engineer
About this role:
A Principal Design Assurance Quality Engineer is a seasoned, experienced professional with wide-ranging experience and expertise in New Product Development and Sustaining quality engineering. The Principal Engineer is responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls and Usability Testing within technical development concepts, new product development and post market product sustaining. Leads and/or participates on fast-paced Cross-Functional Teams to develop and support products throughout the product life cycle, helping to ensure development and maintenance of safe and effective new products. Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining technical objectives of assignment. Selects methods and techniques to lead a project to completion with focus on translating organizational strategy into tactical deliverables. Develops departmental technical policies and procedures. Work is reviewed from a relatively long-term perspective, for desired results.
Your responsibilities include:
Audit Support :
- Execute Quality Deliverables : Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Lead the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead product usability and design validation efforts for new product development and design change projects. Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
- Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
- Suppliers: Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables. Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers. Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Uses diplomacy and tact to resolve difficult situations.
Support internal and external regulatory audits.
What we’re looking for in you:
- Product Support: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques and evaluation criteria for obtaining results. Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s, PIR’s and Field Actions. Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
- Quality System Champion : Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Act as division representative on cross-divisional projects defining the quality system(s). Provides technical leadership to business units. Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives. Promote Boston Scientific values.
- Quality Site Mentor: Interfaces and potentially provides leadership with junior engineering staff to facilitate execution of broader project objectives. Provides direct mentorship in execution of quality deliverables. Works to align on project strategy and helps development of department in quality principles, technology and strategy.
BS in Mechanical, Electrical, Biomedical Engineering or related engineering degree
Minimum of 8 years of Medical device engineering experience;
Travel approximately 10-15% of the time
In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
Strong communication and presentation skills.
Supervisory experience preferred but not required.
Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
10+ years of medical device engineering experience
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Nearest Major Market:
Quality Engineer, Medical, Engineer, Electrical, Engineering, Quality, Healthcare