Design Quality Engineer II

Recruiter: Spencer Gregory Hale

Design Quality Engineer II

About the role:

Boston Scientific Peripheral Interventions has an opportunity for a Design Quality Engineer II to join our Vascular team to grow and develop our portfolio of products. The Design Quality Engineer II will work cross-functionally to ensure safety, performance, and compliance of the device while delivering the highest quality product to the customer. This role will serve as a Quality team member on New Product development (NPD), Sustaining, and/or Integration projects and will utilize quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities will include:

• Be a part of an extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Supports departmental, functional, and divisional design quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Utilizes methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensures adherence to the quality system Policies, SOPs, and work instructions following Boston Scientific's Product Life Cycle Process (PLCP).
• Applies critical thinking and engineering analysis to solve problems.

Required qualifications:

• BS in Mechanical / Biomedical Engineering or related discipline in the sciences.
• 2+years' experience in Design Quality Assurance or related experience in quality engineering or NPD design (or 1 year of experience in Design Quality Assurance or related experience in quality engineering or NPD design with a master's degree in mechanical or biomedical engineering).
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability).
• Ability to travel up to 10%.

Preferred qualifications:

• Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management.
• Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.
• Experience developing and launching Balloon catheter and stent based medical devices.
• Experience with medical device development for single use devices and those containing Electronic Medical Equipment.
• Experience with combination drug-device development
• Ability to work independently and as part of a team.

Requisition ID:611378

Minimum Salary:$69500

Maximum Salary: $132000

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.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.