Additional Locations: US-MN-Arden Hills
Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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 this role:
Responsible for providing leadership to a team of IC Post Market Quality Technicians in the IC Complaint Investigation Site (CIS) that directly support complaint product investigations ranging from Single Use Devices to Capital Equipment to system accessories. The team uses product performance data to escalate Post-Market field performance signals in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety. Key focus is on Operational Excellence and developing Quality Technicians and peer Engineers to improve rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics. This engineer will have an opportunity to participate in standing-up new analytical tools and harmonization of Post-Market Trending and Analysis practices across BSC business units. You will be identifying, coordinating, and assigning project priorities based on business and department objectives. Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. Will help develop a more robust CIS training program and run a Signal Evaluation Review (SER) board providing a cross-site high visibility role.
NOTE: Role will begin in Maple Grove but is projected to move to Arden Hills by Q1 2022.
Your responsibilities will include:
- Providing team leadership to ~ 6 Quality Technicians to champion departmental or cross-functional initiatives. This includes providing direction, coaching, and mentoring to technical team personnel as well as providing guidance on daily work priorities to improve product performance.
- Overseeing effective execution of complaint management WIP and metrics enhancement and reporting including presentations to Director and above leadership.
- Providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques. Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc)
- Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
- Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations.
- Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What we’re looking for in you:
- Bachelor’s degree with an Engineering or Science background with 5+ years of relevant experience
- Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards
- Demonstrated effective change leadership and results-oriented focus
- Demonstrated problem-solving & data analysis capabilities
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
- Ability to collaborate and influence across multiple, cross-functional teams
- Strong ability to successfully multi-task and adaptability
- Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
- 1-2 years of Supervisory experience
- Experience in Medical Device industry
- Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
- Self-starter with the ability to identify improvement opportunities.
- Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
- Familiarity with Post Market requirements and IT systems
Requisition ID: 483903
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.