Design Assurance Engineer II

Additional Locations: Costa Rica-Heredia

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview. 

About the role:

A Design Assurance Engineer II is a quality member that directly supports medical device product development from concept through commercialization. You will support product sustaining activities assessing product performance for trends including signal escalations and design changes. This position will help lead, communicate, and coordinate complaint reduction and post market projects and implementation of design changes. Also, you will guarantee compliance with Quality System Regulations, Corporate Quality Manual and corporate and local standard operating procedures.  

Your Responsibilities Include:

• Collaborate and lead to solve complex engineering problems using analysis, experimentation, and statistics.
• Apply sound, systematic problem-solving methodologies in prioritizing, communicating, and helping resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Intermediate conceptual knowledge of Design Controls. Assist to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
• Collaborate with quality trending using the complaint and NCEP/CAPA systems.
• Assist, communicate, and coordinate complaint reduction and post market projects and initiatives and roll-out with cross-functional teams.
• Communicate product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports. 
• Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management.
• Support and lead project decisions on quality and compliance inputs for post market product sustaining activities, such as design changes, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Contribute with internal and external regulatory audits, as required.
• Cooperate and contribute to developing test method validation protocols and reports, and design verification activities.
• Work with cross functional teams to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components.

What we're looking for:

• Bachelor or Licentiate near-graduates in Chemical, Mechanical, Mechatronics, Materials, Biomedical Engineering or related.
• English Level desired: 85-95%.
• Experience: 2+ years
• Desired knowledge: Problem Solving, critical thinking, statistical tools.
• Ability to collaborate across multiple and cross-functional teams. 
• Strong ability to multi-task and be adaptable.

Preferred Qualifications 

• Strong presentation and facilitation skills.
• Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation, and Quality Standards. 
• Demonstrated understanding of risk management.
• Leadership skills.

Requisition ID: 615244

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!

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.

#CRTA #CRGH #RDCR