Senior Design Assurance Manager- Structural Heart
1 month ago
Additional Location(s): N/A
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.
About the role:
Boston Scientific is recruiting for a Senior Design Assurance Manager at our Maple Grove, MN location. This exciting role involves leading a team within the Structural Heart Valve franchise, focusing on developing and sustaining single-use devices for TAVR, as well as supporting HCP training and clinical therapy development for the portfolio. The role is hybrid with the expectation to be on-site three days a week.
The Senior Design Assurance Manager will provide leadership in design assurance and oversee a team of skilled engineers. The role is responsible for ensuring product quality and compliance by applying Design Control and Risk Management processes. This position is a key partner to the Research & Development, Medical, Regulatory, Marketing, and Manufacturing Engineering teams, contributing to new product development, commercialization, and product sustainment within the rapidly growing Interventional Cardiology (IC) division of Boston Scientific.
Your responsibilities will include:
- Leads quality team on product development projects of major magnitude and scope. Key Quality voice of influence on projects.
- Leads quality team on functional deliverables and ensures technical excellence for product or technical development in the achievement of organizational goals.
- Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance
- Owns and drives commercial product monitoring and all related product sustainment activities.
- Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
- Driving functional excellence in Design Assurance (DA) by developing, coaching, mentoring, and leadership on product design changes, while ensuring technical excellence..
- Develops department budget and monitors spending.Works with key partners to understand priorities and plans resource allocation accordingly.
- Maintains and enhances cross-functional team relationships.
- Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
- Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Directly interfaces with internal and external audit activities.
Required qualifications:
- Bachelor's degreeand 7+ years of related work experience or an equivalent combination of education and work experience
- 5+ years of direct or indirect supervisory experience with a passion for leadership and team development
- Medical Device or regulated industry experience
Preferred qualifications:
- Advanced degree in technical field or business
- Experience leading technical teams
- Prior R&D experience
- Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
- Experience in structural heart valves
#LI-Hybrid
Requisition ID:587000
Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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 (NYSE: BSX) 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
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * , 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.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
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