Design Quality Manager - Interventional Oncology & Embolization

Work mode: Hybrid

Onsite Location(s):

Maple Grove, MN, US, 55311

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: 
The Boston Scientific Interventional Oncology & Embolization (IO&E) organization is the market leader in therapeutics and tools for interventional radiologists, featuring Y90 microspheres, ablation devices, embolic devices and a selection of ancillary products. We are looking for a dynamic Design Quality Manager to lead a team of engineers supporting the growing TheraSphere Y90 franchise. In this role you will work with high-performing cross-functional Sustaining Engineering and New Product Development teams to maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.   

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week.

Relocation assistance:

Relocation assistance is not available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your Responsibilities will include:

Assists in and/or manages functional deliverables and ensures technical excellence for Sustaining Engineering and New Product Development.

Drives functional excellence in Design Quality Assurance by providing leadership, coaching, and mentoring on product design and development, including Risk Management, Design Controls, and Post-Market Surveillance.

Provides leadership, guidance, and approval regarding Quality initiatives including product performance.

Reviews and approves verification and validation plans, protocols, reports, and non-conforming product assessments.

Works cross-functionally in identifying and resolving technical issues, takes a proactive role in collaborating across the organization to mitigate issues.

Works with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time.

Explores opportunities for staff to learn about new initiatives and participate on new projects.

Drives and evaluates process and results for project and department objectives.

Recruits, hires, trains, and develops world-class staff.

Management requirements:

Leads a group or team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization.

Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Directs and controls the activities and budget of one or more functional areas and/or projects/programs.

Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Influences others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we’re looking for in you:

Required qualifications

B.S. Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering.

Bachelor's degree plus 8 years of related work experience or an equivalent combination of education and work experience.

Proven technical leadership and project management skills in medical device design, development, commercial launch, and product sustainment.

Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.

2+ years of experience mento

Requisition ID: 619170

Minimum Salary: $ 99100

Maximum Salary: $ 188300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis
Job Segment: Oncology, Biomedical Engineering, Electrical Engineering, Mechanical Engineer, Risk Management, Healthcare, Engineering, Finance

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