Sr. Product Development Engineer

POSITION SUMMARY:

This position executes and oversees overall Product Development activities, including new Company products. This position maintains the program timeline, the Company Design History Files, and all critical supplier development milestones to ensure alignment and timely achievement of all design control deliverables. This position is responsible for executing the overall Company Design Control requirements, with particular attention to Design History File development and maintenance, including deliverables required of the critical suppliers. This role will ensure ongoing clinical builds of system components meet design control requirements, including overseeing Design History Records and ensuring all build documentation is accurate. This person will oversee Design Verification, Design Validation, Test Method Development and Validation, and Process Validations associated with product lines under development and support Regulatory and Quality requirements to ensure timely approvals for commercialization.

KEY ACCOUNTABILITIES:

· Execute the Product Development design control activities to allow the Company to meet established business goals.

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

· 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 the Company Design History File.

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

· Ensure that documentation and design controls are appropriate for the organization.

· Develop and maintain Design Trace Matrix, product specifications, and detailed drawings associated with the Company system..

· 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, including control boxes, tubing sets, pumps, catheters, and other required materials.

· 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 evaluations of the Company 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 or modified components and/or vendors.

SKILLS/EDUCATION REQUIREMENTS:

· Preferred Product Development catheter experience in the Neurovascular space.

· Minimum 4-year engineering or science degree with Master's or Ph.D. preferred.

· Minimum 5 years’ experience in medical devices with continually increasing responsibilities in product development and management.

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

· Must have a 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 to Company core values.

· 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.

WORK ENVIRONMENT

The work is conducted in an office environment, with some controlled cleanroom activities performed periodically. Experiments and testing are conducted in a laboratory environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

EXEMPT OR NON-EXEMPT: Exempt

TRAVEL REQUIREMENTS: 20% with periods of high travel and other intervals with minimal time away from the office; primarily US, but may require international travel at times.

We are a specialized Global staffing firm that works for Fortune 500 companies in the Medical Device, Pharmaceutical, and Biotec industries, finding qualified personnel.