Additional Location(s): US-MA-Marlborough; US-CA-Valencia; US-MN-Maple Grove; US-MN-Minnetonka
About the role:This Design Assurance Engineer III position will work on the Valencia Technologies Integration project, specifically supporting product Design Control integration. 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.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA, Valencia, CA or Minnetonka, MN and requires being on-site at least three days per week.
Relocation assistance:Relocation assistance is 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: - 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)
- 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
Requisition ID: 631061
Minimum Salary: $82100 Maximum Salary: $156000 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
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
salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for
sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
Our organization is across Canada and has commercial representation in 140 countries.
This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.
As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Design Assurance Engineer III - Urologyposition require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Design Assurance Engineer III - Urology position.
However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee's duties.
