Design Assurance Eng III Job Details | Boston Scientific

Job Description

Design Assurance Eng IIIWork mode: HybridOnsite Location(s): Heredia, H, CRDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 Scientifics hybrid workplace includes WFH 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 but also will support development products 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 quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues. Successfully navigates in grey spaces and provides logical and creative ideas to the teams.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. 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: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Translates customer needs into product requirements and design specifications.
• Responsible for revision of engineering and validation documentation.
• Works under general direction regarding the progress of projects and special assignments. Independently determines and develops approach to solutions.
• Support internal and external regulatory audits as required.

Required qualifications:

• Bachelors degree in Electronic, Industrial, Electromechanical Engineering or related Field.
• English Level desired: 80-89 PERCENT .
• At least 3 years of experience in similar positions.

Preferred qualifications:

• Be able to influence across functional teams (manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering) and driving projects to completion.
• In depth familiarity with the FDA, ISO, MDD, 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.
• Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
• High energy problem solver capable of driving items to closure.
• Strong communication (oral and written) and presentation skills.

Requisition ID: 594044As 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) isnt just business, its personal. And if youre 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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.Job Segment: R&D Engineer, Medical Research, Clinical Research, Risk Management, Medical Device, Engineering, Healthcare, Finance

Keyskills :
design assurance engineering risk management expertise problem solving methodologies quality system management regulatory compliance knowledgeiso safety manufacturing technology development innovation process study quality initiatives engineer