Design Quality Assurance 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 Working from Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role: 

This position will oversee the sustaining activities for our Single Use Devices for the rapidly growing Electrophysiology division. It will have direct interaction with our Heredia and Arden Hills sites but also working closely with our Montreal and Waltham design sites.

Provide Design Assurance Engineering support to Arden Hills and Heredia for the commercial product in the market ensuring delivery of the highest quality result to the customer while supporting continuous improvement projects and quality initiatives.  This role will partner with Research & Development, Post Market and manufacturing site for support, among others.

Your responsibilities will include:

• Demonstrates knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance.
• Be able to own with supervision, quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
• Applies systematic problem-solving methodologies in identifying, communicating, and resolving issues. Be able to navigate in grey spaces and provides logical and creative ideas to the teams.
• Works with internal customers who represent related and interconnected processes such as Design Controls, Risk Management, Post Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.

• Successfully completes engineering work in one or more of the following: product design and development, test of products, preparation of specifications, process study, research investigation and report preparation.
• Understand the customer needs and how they are translated to product requirements and design specifications.
• Responsible for revision of engineering and validation documentation.
• Support internal and external regulatory audits as required.

Minimum qualifications:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
• English Level required: B2:(70-79%).
• At least 2 years of experience in similar position.

Preferred qualifications:

• Be able to influence across functional teams (manufacturing roles, post market complaints, CAPA, risk management, supplier quality, and process engineering) and driving projects to completion.
• Be familiar with the FDA, ISO, MDD, MDR, and the medical device industry quality requirements associated with product design & development and product risk management.
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• High energy problem solver capable of driving items to closure. 
• Strong communication (oral and written) and presentation skills. 

Requisition ID: 603427

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.