Senior Product Development Manager - Direct Hire In Michigan
Kelly Engineering Resources (Ann Arbor, Michigan)

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We have a medical device client in Ann Arbor, Michigan seeking a Senior Product Development Manager. This position is responsible for product development from the initial creative idea to final design and manufacturing to include following guidelines in GMP, FDA, 510(k), PMA, QA and RA. You must have medical device industry experience. Seeking candidates with at least 10 years of product development experience in the medical device industry. Strong electro-mechanical experience with the medical device industry is required. If you do not have this experience, please do not apply. There are up nine direct engineers reporting to this position. Manager directly reports to the V.P. of Product Development. Salary range is firm from 125,000 to 135,000 in base salary with a potential bonus of 15%. Reasonable re-location package is an option if necessary. Job Description: This position is responsible for developing new products in support of a strategic plan. Responsible for the initiation and completion of development projects on time and within budget. Supervise and develop engineers or other direct reports. Maintain and follow proper compliance and quality systems requirements. Lead and manage cross-functional product development teams in the design and development of cardiovascular surgery products. Plan and formulate aspects of new project proposals. Develop and assess new technologies and product ideas for profitability, fit, feasibility, safety and effectiveness. Work closely with other engineering managers and project leaders to drive projects to completion within identified schedule and budget constraints. Provide engineering support to the manufacturing, quality and marketing departments. Carry out supervisory responsibilities in accordance with the organization's policies. Create and revise procedures to assure compliance with the ISO directive and medical device regulations. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for department and company performance improvement. Education and Experience Required: Requires a four-year college degree in Engineering or Sciences coupled with at least 10 years of experience in product development. Masters degree in appropriate discipline preferred. At least 5 years of prior engineering-related supervisor/project leadership experience in the medical device industry required. Demonstrated high degree of creativity, foresight, and sound judgment in planning, organizing, and leading engineering projects and activities. Background in 510(k) required. Knowledge of PMAs helpful. Familiar with GMP and ISO regulations. Exposure to QA, RA and manufacturing. Solid track record of successful product introductions from concept to manufacturing. Excellent communication and people skills. Knowledge of finance to work with and understand general cost accounting principles.