Principal Mechanical Engineer - Fort Lauderdale, Florida | CareerCircle
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Principal Mechanical Engineer

Actalent

02/22/2022

Posting ID: JP-002663291

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Fort Lauderdale, Florida
Full Time
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Description:

The role oversees technical project needs such as developing and implementing product test methods and conducting the overall design verification and validation activities. Experience with Design for Manufacturing to ensure the system will smoothly transition into a commercial product is critical. This position is responsible for establishing, developing, and managing the overall Design Control requirements, with particular attention to Design History File development and maintenance, including deliverables required of the critical suppliers. The role will ensure initial clinical builds of system components are conducted within design control requirements, including overseeing Design History Records, and ensuring all build documentation is accurate.

KEY ACCOUNTABILITIES:

• Develop a deep understanding of the technology, including electromechanical systems and disposable sub-systems.

• Drive product design efforts locally and at suppliers.

• Create, review, and approve prototype and production product designs.

• Develop and implement product-related test methods and drive all design verification and validation activities.

• Ensure system design is easy to manufacture to ensure the system will smoothly transition into a commercial product.

• Lead the Product Development design control activities for to allow to meet established business goals.

• Interface with internal and external customers including Clinical/Regulatory and leading Physicians to define and clearly document product specifications for new products.

• Interface with external suppliers and customers who are jointly involved in product development. Ensure all design control documentation is incorporated and accessible in Design History File.

• Manage the design control process for specified new products in compliance with both CFR Part 21 and ISO 13485

• Ensure that documentation and design controls are appropriate for organization.

• Develop and maintain Design Trace Matrix, product specification, and detailed drawings associated with the system.

• Oversee and mentor the product development engineers and technicians in the development of new products and improvements to existing products.

• Identify new product development ideas and participate in the decision-making process to pursue the product and prioritize the efforts.

• Serve as design representative for regulatory audits.

• Responsible for creating and maintaining all documentation and records associated with internal product manufacturing activities.

• Ensure adequate materials and components are available when needed for manufacturing and testing activities.

• Ensure hospitals conducting evaluations have adequate materials to complete the cases.

• Prepare summary reports for the development team with regular updates on the physician feedback and case results.

• Write various evaluation, verification, animal and/or validation test protocols and reports to support the product development process through design controls.

• As necessary, build test equipment and conduct testing of product as needed.

• Learn the product design and procedural steps to effectively act as the main contact for various clinical evaluations of product.

• Create, review, and approve prototype and production tooling drawings and manufacturing procedures.

• Maintain a working knowledge of company procedures, FDA Quality System Regulation, and ISO 13485.

• Evaluate new components and new vendors.

Skills:

electro mechanical, medical device, design control

Top Skills Details:

electro mechanical,medical device,design control

Additional Skills & Qualifications:

Must:

• Minimum 10 years’ experience in medical devices in continually increasing responsibilities of product development and management responsibility.

• Must have experience and knowledge with Design for Manufacturing tools and transitioning a design into a manufacturing environment for commercial production.

• Must have experience developing product test methods and driving design verification and validation testing.

Plus:

• Must have experience taking medical devices from concept through commercialization.

• Must have Design for Excellence (DFX) experience.

• Must have previous experience in engineering management or project management.

• Must have thorough understanding of product development processes, manufacturing processes, quality assurance and project planning.

• Software skills should include MS Excel, MS Word, MS Project and Solidworks. Overall, must be computer literate.

• Possess personal qualities of integrity, credibility, and commitment

• Understanding of quality system regulations (ISO13485, 21CFR820)

• Must have strong interpersonal, written, and oral communication, organizational, and planning skills.

• Excellent presentation skills.

• Must be able to be a team player and work with cross-functional teams.

• Must be able to make decisions based on experience, facts and intelligent risk taking.

• Works independently with little guidance.

• Must be able to effectively interface with Physicians.

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Spencer Parker

Phone: +14105671334

Email: spparker@actalentservices.com

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