Senior Design Quality Assurance Engineer
4 weeks ago
The Senior Design Quality Assurance Engineer is a seasoned professional with extensive experience and expertise in quality engineering and regulatory requirements applicable to the medical device industry. This role will develop, establish, and maintain quality engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements.
This is a hybrid position based out of Marlborough, MA, with the expectation to be in the office a minimum of three days per week.
Your responsibilities include:- Providing quality and compliance input and coaching for product development and/or post-market product sustaining activities, such as EUMDR Notified Body questions, Product Inquiry Reports (PIR), Additional Information (AI) requests, CE marking, Design Changes, NCEP's, and CAPA's.
- Promoting Cross-Functional collaboration and having the ability to influence project strategy. Capable of working independently on highly specialized projects with long-range objectives.
- Leading the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Usability Validation Plans. Leading the execution of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrating a primary commitment to patient safety.
- Providing project direction, coaching, and mentoring for engineering and technical team personnel.
- Developing solutions to complex and diverse technical problems that require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.
- Proactively investigating, identifying, and implementing best-in-class Quality Engineering practices. Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Supporting internal and external regulatory audits. External audit facing.
- Providing technical leadership to business units. Advising management on potential improvements or enhancements to quality systems and processes.
- Supporting the development, implementation, and training of corporate quality initiatives.
- Bachelor of Science in Biomedical, Mechanical Engineering, or related degree.
- Minimum of 5 years of medical device engineering experience.
- 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.
- Strong communication and presentation skills.
- Solid technical writing skills.
- Travel
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the Role:We are seeking a highly skilled Senior Design Assurance Engineer to join our team at Boston Scientific Gruppe. As a key member of our Interventional Cardiology division, you will be responsible for supporting the development and commercialization of single-use devices for percutaneous coronary intervention (PCI).Your Key...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout Boston Scientific GruppeWe're a leading medical device company that's passionate about making a difference in people's lives. Our team is dedicated to developing innovative solutions that improve patient outcomes and enhance the quality of life.Job SummaryWe're seeking a highly skilled Senior Design Assurance Engineer to join our Interventional...
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Senior Design Assurance Engineer
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout Boston Scientific GruppeWe're a global leader in medical technology, dedicated to improving patient outcomes and transforming healthcare. Our team is passionate about innovation, diversity, and collaboration, and we're committed to making a positive impact on people's lives.Job SummaryWe're seeking a Senior Design Assurance Engineer to join our...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Senior Design Quality Engineer to join our Interventional Cardiology division. As a key member of our team, you will be responsible for ensuring the quality and safety of our percutaneous coronary intervention (PCI) single-use devices.Key ResponsibilitiesSupport the execution and documentation of Design...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Senior Design Quality Engineer to join our Interventional Cardiology division. As a key member of our team, you will be responsible for ensuring the quality and safety of our percutaneous coronary intervention (PCI) single-use devices.Key ResponsibilitiesSupport the execution and documentation of Design...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Senior Design Quality Engineer to join our team in the Interventional Cardiology division. As a key member of our cross-functional team, you will be responsible for ensuring the quality and safety of our percutaneous coronary intervention (PCI) single-use devices.Your primary focus will be on applying design...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Engineer to join our Nitinol Shape Memory WATCHMAN team. As a key member of our team, you will provide line support and support key projects for improved process control and higher production capacity.This role will partner with representatives from R&D, Design Assurance, Process Development,...
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Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Engineer to join our Nitinol Shape Memory WATCHMAN team. As a key member of our team, you will provide line support and support key projects for improved process control and higher production capacity.This role will partner with representatives from R&D, Design Assurance, Process Development,...
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