Insight Global
Design Assurance Director
Insight Global, Cambridge, Massachusetts, us, 02140
Insight Global - Design Assurance Director - Cambridge, Massachusetts Insight Global is seeking a Design Assurance leader to join a growing division in one of the nation's largest and most successful Medical Device companies. The Design Assurance Director will serve as the Site Head of Quality in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having direct interaction with national and global sites.
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.This candidate will lead a team in developing and sustaining medical electrical equipment/systems and developing a strong System of System Organization focus on building expertise in Medical Device manufacturing, Cybersecurity, Reliability, and other related topics. The Design Assurance Director will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management.The Design Assurance Director will be a key partner to the Research & Development, Regulatory, Post Market Quality, Supplier Quality, Marketing, and Manufacturing Engineering teams in achieving new product development, commercialization, and product sustainment.Minimum Requirements:At least 10 years of relevant experience, with at least 5 years of leadership experience.Bachelor's degree in an engineering discipline.Experience working in a design assurance role focused on R&D within a Medical Device company.Experience leading technical teams.Advanced degree in technical fields.Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.
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Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.This candidate will lead a team in developing and sustaining medical electrical equipment/systems and developing a strong System of System Organization focus on building expertise in Medical Device manufacturing, Cybersecurity, Reliability, and other related topics. The Design Assurance Director will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management.The Design Assurance Director will be a key partner to the Research & Development, Regulatory, Post Market Quality, Supplier Quality, Marketing, and Manufacturing Engineering teams in achieving new product development, commercialization, and product sustainment.Minimum Requirements:At least 10 years of relevant experience, with at least 5 years of leadership experience.Bachelor's degree in an engineering discipline.Experience working in a design assurance role focused on R&D within a Medical Device company.Experience leading technical teams.Advanced degree in technical fields.Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.
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