Design Assurance Engineer III - Valencia Technologies Integration

Additional Location(s): N/A

About the Role

This Design Assurance Engineer III position will work on the Valencia Technologies Integration project, specifically supporting product Design Control integration and sustaining efforts. 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 hybrid role is based in Marlborough, MA or Maple Grove, MN and requires being on-site at least three days per week. Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Responsibilities

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Act 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, controlled, and implemented appropriately (i.e., EN 13485 / CFR820).
• 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).
• Support Risk Management planning, updating, and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis, and Fault Tree Analysis, etc.) in compliance with Boston Scientific or Valencia Technologies procedures and external standards (e.g., EN 14971).
• 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.

Requirements

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• 3+ 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.

Pay

Minimum Salary: $82,100
Maximum Salary: $156,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific 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.

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).

Benefits

For details on employee benefits offered by Boston Scientific, see www.bscbenefitsconnect.com.