16 days old

Product Design Specialist

Kelly Services
Waukegan, IL 60079
Kelly Engineering has a Direct Hire opportunity for a Product Design Specialist located in Waukegan, IL!

Job Summary:

The Product Design Specialist is responsible for surgical kit and medical device development projects starting from assembly exploration, product definition and labeling to ensuring product set up is complete and registered accordingly with FDA prior to sending to manufacturing. This position will be a subject matter expert on all phases of product development and will be responsible for leading product development efforts while ensuring that project timelines, regulatory compliance, and design requirements are met.

Key Responsibilities:

+ Responsible for facilitating new kit development/design and/or changes to existing surgical kits

+ Collaborates with other functional team members on researching requirements, driving design verification and validation to ensure the safety and efficacy of new product submissions

+ Verifies routers and kit assembly instructions meet all requirements

+ Creates and validates product labels ensuring all requirements are met

+ Collaborates with other functional team members on researching requirements, driving design verification and validation to ensure the safety and efficacy of new product submissions

+ Ensures product design meets all design requirement

+ Works cross-functionally with engineering, quality, regulatory, marketing, and management teams to align project schedules, drive product delivery, and maintain regulatory standards compliance.

+ Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, cost saving opportunities, etc.

+ Coordinate and support all phases of product development from ideation to 510k application to product launch

+ Document all phases of product development system level of products to include in a Design History Record DHR including user needs assessment, design inputs, design outputs, verification, validation, and risk management


+ Bachelor s Degree with experience in developing medical devices, drug delivery devices, combination products and/or pharmaceuticals

+ Experience preferred with medical device requirements Class I-II , design controls, risk assessments, and the 510k process

+ Experience preferred with designing and/or helping launch at least one class II medical device to market, preferred

+ Basic understanding of engineering principles, system design, traceability, and risk management

+ Experience with design verification and validation a plus

+ Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues

+ Ability to work effectively on cross-functional teams

+ Computer proficiency in Microsoft Office products Access, Excel, Outlook, PowerPoint, Word

+ Learns fast, grasps the essence and can change course quickly were indicated

+ Proven ability to succeed in a fast-paced, challenging, and complex environment

+ Excellent organizational and communication skills written and verbal Excellent analytical and problem-solving skills


Health Insurance Medical/Dental/Vision, Life Insurance, 401k with Company Match, Paid Time Off PTO , Employee Referral Program, and more



**Why Kelly** **** **Engineering?**

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-07-29 Expires: 2022-09-08

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Product Design Specialist

Kelly Services
Waukegan, IL 60079

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