Additional Locations: (n/a)
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Defined Term – 12 months
About the role:
The Engineer is responsible to provide support in Regulated Materials and will Develop, establish and maintain Risk Management and Post Market Surveillance related activities and deliverables. Will provide focused Quality Assurance Engineering support within new product development, Post Market, operational, or system/services support.
Support of new product development, regulatory submissions and manufacturing and engineering changes to meet business objectives. Additionally this position is responsible to Develop, implement, maintain and improve appropriate quality system elements to ensure the high quality level of new and existing products. Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
Your responsibilities include:
- Proactively investigates, identifies, and implements best-in-class Quality Assurance Engineering practices.
- Demonstrate a primary commitment to patient safety and product quality.
- This position is responsible for writing and approving Non conformance reports, CAPA's, Test Protocols, Reports, assessing test data, and sending out test samples.
- Provide guidance and interpretation of regulatory requirements related to medical device submissions.
- Provide Quality Engineering support for Operations to ensure adequate quality system controls and resolve quality issues. Schedule, coordinate and monitor a wide variety of tests which are preformed in accordance with approved protocol. Reviews results and final report or qualification.
- Provide guidance to the team on the application of the internal and external regulatory requirements.
- Participate in strategic planning for overall company product quality and processes to help determine key performance indicators and the resulting required actions.
- Independently manage projects and provide guidance to other junior QA personnel.
- Lead Quality Engineering activities such as Quality planning, Risk analysis, FMEA and Design Reviews.
- Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities and manufacturing/inspection methods and equipment.
- Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other QA engineering areas.
- Define processes for planning and conducting in depth reviews, testing and verification/validation of product features and also executing according to the defined processes.
- Responsible for conducting internal audits on department test methods and activities to confirm compliance and to identify improvement opportunity.
- Change control processes (PCAF, DCAF, CRs, SCIAs).
- Perform quality trending using the NCEP/CAPA system. Perform failure analyses and defect investigations. Resolve production quality issues and approves material dispositions and non-standard rework. Perform and/or lead risk analyses and failure investigations for CAPA and/or audit findings investigations.
- Create, revise, and approve departmental procedures.
- Provide leadership role in championing departmental or cross-functional engineering initiatives.
- Provide project direction, coaching, and mentoring for engineering and technical team personnel.
What we’re looking for:
- Minimum of a bachelor’s degree in engineering or a related scientific field is required
- A minimum of 5 years of experience in FDA-regulated Medical Device or similarly regulated industries in Quality Engineering in a medical device, pharmaceutical, and/or consumer product company is required in the quality assurance, failure analysis or product development
- In-depth understanding of statistical techniques such as normality analysis, confidence intervals and should be able to analyze and interpret data with high confidence.
- Able to manage multiple complex projects simultaneously.
- Ability to work collaboratively as a team member across various functions in a challenging and changing environment is required
- Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred
- Proven experience with project management skills, leading safety evaluation for multiple projects, managing priorities and time management is required
- Ability to adapt quickly to change and work in a rapidly changing environment.
- Demonstrated experience in medical device product development from concept through production.
Bachelor’s degree in engineering or equivalent field.
Six Sigma experience/ Black Belt certification.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 450679