Boston Scientific
Design Assurance Engineer, Senior (Electrophysiology (EP)
Boston Scientific, Aurora, Colorado, United States, 80012
Additional Locations:
Costa Rica-Heredia
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles:
Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.
About the role: We have an exciting opportunity for a Design Assurance Engineer supporting front end EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The DA Engineer will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer.
Your responsibilities include:
Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements.
Leads the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
Expertise in the validation and statistical techniques to comply with associated regulatory requirements and internal standards.
Able to navigate gray space by applying risk-based criteria to prioritize project work.
Leads cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
Ability to work with minimal supervision and self-learning skills.
Required Qualifications:
Minimum of a bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
English Level desired: 80-89%.
Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development or related medical device experience.
ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
Preferred Qualifications:
Self-motivated with a passion for solving problems and a bias for action.
Ability to manage multiple priorities and work with ambiguity.
Hands‑on approach to product development.
Strong communication skills (verbal & written).
Proficiency in collaborating with interdisciplinary teams.
Requisition ID:
618702
Benefits • Life‑Work Integration • Community • Career Growth
#J-18808-Ljbffr
Costa Rica-Heredia
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles:
Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.
About the role: We have an exciting opportunity for a Design Assurance Engineer supporting front end EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The DA Engineer will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer.
Your responsibilities include:
Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements.
Leads the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
Expertise in the validation and statistical techniques to comply with associated regulatory requirements and internal standards.
Able to navigate gray space by applying risk-based criteria to prioritize project work.
Leads cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
Ability to work with minimal supervision and self-learning skills.
Required Qualifications:
Minimum of a bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
English Level desired: 80-89%.
Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development or related medical device experience.
ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
Preferred Qualifications:
Self-motivated with a passion for solving problems and a bias for action.
Ability to manage multiple priorities and work with ambiguity.
Hands‑on approach to product development.
Strong communication skills (verbal & written).
Proficiency in collaborating with interdisciplinary teams.
Requisition ID:
618702
Benefits • Life‑Work Integration • Community • Career Growth
#J-18808-Ljbffr