Senior Design Assurance Engineer - Electrophysiology

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

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 the role 

Our team is growing, and we are currently looking for a Senior Design Assurance Engineer to join our Design Assurance team. This position works closely with New Product Development and Product Life Cycle teams to ensure risk management is applied, adequate design controls are met, and subsequent production and process controls are adequate. This position will focus on Design Assurance for packaging and labeling for single use medical devices, capital equipment, and accessories. 

Your responsibilities will include: 

• Serve as an effective quality leader or team member on multiple cross-functional product development teams and/or product sustaining teams. 

• Add to and promote the culture of quality-centric patient care and customer satisfaction within projects and teams. 

• Support junior team members by setting an example, coaching and providing feedback and guidance. 

• Independently, or as a member of a team, develop, direct, and execute plans for design control and risk management of complex projects. 

• Provide quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). 

• Lead the development, implementation, and maintenance of product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs. 

• Use clinical knowledge/data to influence how packaging is tested and designed. 

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 

• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. 

• Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions. 

• Build quality into all aspects of work by maintaining compliance to all quality requirements. 

• Plan, organize and prioritize own daily work routine to meet established schedule. 

• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 

• Other duties as required. 

Required qualifications: 

• Bachelor's Degree in Biomedical / Mechanical Engineering or related field of study 

• 5+ years of related work experience in design assurance, sustaining engineering, or related medical device experience 

• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why’s 

• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Management

• Demonstrated interpersonal skills with ability to work within a team environment

• Strong written/verbal communication skills

• Must be able to work independently under limited supervision

Preferred qualifications: 

• Experience writing Design History File (DHF) documentation 

• Experience in design engineering or process development, including test method validation and process validation

• Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA) 

• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics

• Experience providing mentorship or guidance to junior team members

• Training experience to FDA regulations or other ISO standards

Requisition ID: 602371

Minimum Salary: $79700 

Maximum Salary: $158200 

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).

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!