Principal Design Assurance Engineer - Field CAPA (CRMDx)

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific is seeking a Principal Design Assurance Engineer for Field CAPA (CRMDx) in Arden Hills, MN. The role leads cross‑functional teams to investigate product performance issues (NCEPs, PIRs, CAPAs) and to implement effective CAPA solutions, partnering with R&D, Regulatory, Manufacturing and quality organizations.

The position emphasizes leadership, complex problem‑solving, and project management, with on‑site work at least three days per week and relocation support not offered at

Qualifications

• Bachelor's degree in engineering or related field with 8+ years of experience, or MS with 6+ years.
• Experience with Quality System Regulations, Medical Device Regulation, and ISO13485.
• Experience in Medical Device industry.

Responsibilities

• Leads cross‑functional teams on complex product performance investigations (NCEPs, PIRs, CAPAs).
• Facilitates high-performing teams toward goals and timelines.
• Uses disciplined problem-solving techniques (DMAIC, 5 Whys, cause & effect).
• Maintains documentation per Good Documentation Practice.
• Represents NCEPs, PIRs, CAPAs in audits.
• Mentors cross‑functional teams in NCEPs, CAPAs, PIRs.
• Engages in Global Communities of Practice for improvement.
• Ensures compliance with Quality Policy and procedures.

Skills

NCEPs

CAPAs

PIRs

Root Cause Analysis

DMAIC

5 Whys

Cause & Effect Diagram

Statistics

Microsoft Office

MINITAB

Weibull++

Communication

Leadership

Project Management

Education

Bachelor's or MS in engineering

Tools

MINITAB

Weibull++

Microsoft Office

Job description

Principal Design Assurance Engineer - Field CAPA (CRMDx)

Onsite Location(s): Arden Hills, MN, US, 55112

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 This Role:

This Principal Design Assurance Engineer on the Field CAPA team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role is a tremendous opportunity for a strong technical individual, with an innate technical curiosity, who is seeking leadership, complex problem-solving, and project management experience. The role also provides great exposure to the intricacies of how CRMDx products function, are designed, and the many parts of the organization that support their commercial use. This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results. May serve as liaison between the company and the various governmental agencies worldwide.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, 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.

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

Your Responsibilities Will Include:

• Leads cross‑functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Product Inquiry Reports (PIRs), and Corrective and Preventive Actions (CAPAs). Expected to facilitate high performing teams working towards common goals and timelines.
• Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.
• Creates, maintains, and enhances cross‑functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross‑functionally and across multiple sites in identifying and resolving technical issues. Represents the team at key global and divisional leadership forums.
• Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines.
• Creates, reviews, and approves Quality System records for NCEPs, PIRs, and CAPAs. May represent NCEPs, PIRs, and CAPAs in internal and external audits.
• Presents updates in formal and informal reviews with all levels of the organization including high senior leadership at Boston Scientific.
• Mentors and guides other cross‑functional teams and engineers by providing technical guidance and consulting on execution of NCEPs, CAPAs, and PIRs. May include consulting across other BSC divisions.
• Participates on behalf of the Field CAPA or Design Assurance team at large in Global Communities of Practice to foster cross‑communication, best practices, and improvement to investigational processes and outcomes.
• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• 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.
• 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

• Bachelors degree in an engineering or related discipline with 8+ years of relevant experience or MS with 6+ years of experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
• Experience in Medical Device industry

Preferred Qualifications

• Experience with NCEPs, CAPAs, PIRs and other investigation processes.
• Experience with Active Implantable technologies and the CRMDx division
• Demonstrated technical problem-solving & data analysis capabilities
• Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)
• Strong ability to successfully multi-task and demonstrate adaptability
• Project management experience (direct or cross‑functional teams)
• Demonstrated effective change leadership and results‑oriented focus
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross‑functional teams
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Self‑starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.

Requisition ID:633367

Minimum Salary:$102100

Maximum Salary: $194000

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high‑performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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 specificprohibited substancetest 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.