Additional Location(s): N/A
About the role:This Senior Design Assurance Engineer will work on the Axonics Integration project, specifically supporting product Design Control integration under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements. This Design Quality role supports the active implantable design process for both existing and new products.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. In this position, you can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA.
Relocation assistance is available for this position.
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include: - Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Acts as an effective team member in supporting quality disciplines, decisions, and practices
- Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
- Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
- Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities
- Support Post Market activities, as necessary, of risk based on post-market signals
- Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
- Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
- Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Partner cross-functionally to identify and support value improvement efforts to support business goals
What we're looking for in you: Required qualifications:
- Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
- 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
- Self-motivated with a passion for solving problems and a bias for action
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies
- Ability to effectively work and collaborate in a mixed onsite + remote environment
- Demonstrated experience creating detailed technical documents
Preferred qualifications:
- Experience working with medical electrical equipment and/or active implantables
- Quality Integration experience
- ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
- Experienced problem solver, capable of facilitating the problem-solving process
- Adaptable and effective collaborator in a team environment or in self-directed work
- Experience with design changes, complaint reduction, and corrective action
Requisition ID: 628585Minimum Salary: $ 85000 Maximum Salary: $ 161500 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.
