Job Information
Insight Global Design Control & Risk Management Lead for Combination Products in Rahway, New Jersey
Job Description
One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management Engineer on the Combination Product Team, specializing in a unique drug delivery product. This team supports new product development, commercialization and life-cycle management activities of medical device and combination products. They will be responsible for supporting projects surrounding a specialized drug delivery method and the strategy to support clinical studies/commercialization. You would be heavily involved in leading meetings to define requirements, risk, and support development for ocular and auto-injector programs. You will be working with cross-functional partners on deliverables required to get the project to major clinical studies.
Responsibilities:
Lead the creation of Device Development, Design Control and Risk Management deliverables for the assigned projects.
Lead the implementation and/or ensures effective execution of the Device Development Strategy, Design Control and Risk Management activities for the assigned projects.
-Proactively resolve project obstacles and challenges
-Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
-Lead conversations with external suppliers
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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Skills and Requirements
10 years' experience in Medical Device
Combination Product/Drug Delivery experience, specifically with Auto Injectors
Design Control & Risk Management experience
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering. null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.