Design Assurance Engineer I

Design Assurance Engineer I

Work mode: Hybrid

Onsite Location(s): American Free Zone, San Franci, CR

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

The Design Assurance Engineer/Assistant 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 complaints and signal escalations. This position will help lead, communicate, and coordinate complaint reduction and post market projects and initiatives. Also, you will guarantee compliance with Quality System Regulations, Corporate Quality Manual and corporate and local standard operating procedures.

Your responsibilities include:

• Collaborate to solve complex engineering problems using analysis, experimentation, and statistics.
• Apply sound, systematic problem-solving methodologies in prioritizing, communicating, and helping resolve quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Basic 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.
• Assist during 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.

Required Qualifications

• Bachelor or Licenciature degree in Chemical, Mechanical, Mechatronics, Materials, Biomedical Engineering or related.
• English Level desired: 85-95%.
• 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.

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 purposeimproving lives through your life's work.