- Bachelor's Degree
- Master's Degree
- Communication Skills
- Statistical Software
- FDA Regulations
- Microsoft Office
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.
Sr. Quality Engineer New Product Development
About this role:
A New Product Development Senior Design Assurance Quality 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 and new product development. Works in fast paced Cross-Functional Teams to develop and support New Product Development, helping to ensure development of safe and effective new products. Supports Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.
Your responsibilities include:
Execute Quality Deliverables : Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, and Software Validation Plan. 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.
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.
Audit Support: Support internal and external regulatory audits.
Product Support: Provide key quality trending information and data for Management Review and Complaint Reviews. 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 : Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives.
What we’re looking for in you:
A commitment to our Vision to be a trusted design partner of choice that uses our specialized knowledge to deliver quality results for our customers by being Engaged, Communicative, Thoughtful, Proactive, Trustworthy and a Steward of Best Practice.
BS in Mechanical, Electrical, or Biomedical Engineering
Minimum of 5 years of Medical device engineering experience;
Travel approximately 10-15% of the time
In depth familiarity with the FDA, ISO, MDD 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, and EN 62366.
Strong communication and presentation skills.
Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
MS strongly preferred.
7 + years of medical device engineering experience preferred .
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
Requisition ID: 452723
Nearest Major Market: Boston
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