Product Development Specialist
hace 7 días
About Us
Boston Scientific is a leading medical device manufacturer committed to advancing science for life. With over 40 years of experience, we strive to solve the most pressing healthcare challenges. Our mission is to improve patient lives through innovative medical solutions that create value for our customers and support our employees and communities.
Job Summary
We are seeking a highly skilled Design Assurance Engineer II to oversee sustaining activities for our Single Use Devices in the rapidly growing Electrophysiology division. This role will involve direct interaction with our Heredia and Arden Hills sites, as well as collaboration with our Montreal and Waltham design sites.
Key Responsibilities
Demonstrate knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance principles.Owning quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management with supervision.Apply systematic problem-solving methodologies to identify, communicate, and resolve issues.Navigate grey spaces and provide logical and creative ideas to teams.Work with internal customers representing related processes such as Design Controls, Risk Management, Post-Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.Successfully complete engineering work in product design and development, test of products, preparation of specifications, process study, research investigation, and report preparation.Requirements
To be successful in this role, you will need:
A Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.English Level required: B2 (70-79%).At least 2 years of experience in a similar position.Preferred Qualifications
The ideal candidate will have:
Influence across functional teams (manufacturing roles, post-market complaints, CAPA, risk management, supplier quality, and process engineering) and drive projects to completion.Familiarity with FDA, ISO, MDD, MDR, and medical device industry quality requirements associated with product design & development and product risk management.The ability to work in a fast-paced, dynamic environment while promoting cross-functional teamwork.Strong communication (oral and written) and presentation skills.-
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