Easter Seals Jobs

Job Description

One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management lead, supporting the Combination Product, Device Development Team. This project is focusing on autoinjectors and they will be

responsible for leading and implementing Medical Device & Combination Product Design Control & Risk Management activities for new products from early design concept, clinical and through commercialization. This position will interact with cross-functional development teams and within Device Development. This resource must be able to work well with all levels of employees and be able to effectively coordinate the execution of autoinjector device development strategies.

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

This is a hybrid role, 3 days onsite, 2 WFH.

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

5 years' experience in Combination Product Or Medical Device

Design Control & Risk Management experience

Lead and authoring of design control & risk management deliverables

B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering. Combination Product experience

Experience working on an Autoinjector, or on-body device

Regulatory Intelligence 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.