Quality Design Engineer
18 hours ago
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
Job Purpose
Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Key Responsibilities
- Responsible for the quality of state-of-the-art products within a highly regulated product line up.
- Responsible for product DHF and DHR documentation.
- Analyses and reports to management on product performance.
- Analyses and acts on product complaints.
- Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Responsible for assuring the product design compliant to IEC 60601 (inclusive of EMC), IPC-A-610 etc.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Participates in Customer Complaints investigation for areas under their control.
- Continually seeks to drive improvements in product and process quality.
- Knowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
- Lead proactive design assurance activities facilitating the development and release of high-quality products.
- Review and approve product design documents in accordance with design controls standards and company’s policies. This includes but is not limited to design verification and design validation activities.
- Partnering with R&D to ensure design control processes are maintained and continuously improved while ensuring on-going compliance to all applicable regulation and standards.
- Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
- Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
- Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.
Education & Experience
- Bachelors’ degree in Life Science, Engineering field or second degree in fields of quality and statistics.
- Proven experience in quality systems (4-5 years) and in medical device field (minimum 3 years). Electronics and embedded software experience in a Design quality assurance capacity would be advantageous.
- Experience working in an FDA and ISO 13485 regulated environment.
- Project management skills, strong communication, problem solving, and analytical skills are required.
- Leadership skills without direct authority responsibility.
- No supervisory responsibility; may provide informal guidance to new team members.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
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