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Approvals Engineering Team Leader

Company Name:
Stryker Medical A Division of Stryker Corporation
Ensure conformance to U.S. and international electrical, mechanical, and software standards, regulations, and initiatives; provide direction and support to cross functional team members with respect to compliance testing, design, and sustainment activities in relation to approvals engineering activities; develop, maintain and revise the approvals engineering schedules to ensure project timelines are met; participate in audits by regulatory compliance agencies in order to provide expertise and input for technical issues, actions or decisions; develop status reports and other related communications; responsible for primary hiring, on-time performance appraisals, coaching/counseling, employee development and necessary communications regarding performance issues; plan, organize, staff, direct and control the engineering function within appropriate guidelines, policies and regulations; establish and guide goals and accomplishments of the team; provide input to finance department and manager to create budgets and financial projects; monitor and control team spending to achieve budget objectives; plan and coordinate with other engineering areas to ensure the timely and efficient project execution; work as a key member of an interdisciplinary business team to drive business performance; drive and develop increased team engagement over time; assist leadership in developing strategic direction and achieving goals. Travel up to 25% to support business needs.
Requirements must include: Bachelors degree in engineering and one (1) year of experience in job offered or as a technical manager in approvals engineering, research and development, quality assurance, regulatory affairs, or related occupation. In lieu of one (1) year of experience as a manager, will accept three (3) years of experience as an engineer working with technical standards such as IEC 60601. Experience must include: experience working in the medical device industry or similarly regulated environment; FDA and ISO design and process control systems; ERP; statistics; manufacturing processes; metrology; auditing; mechanical support; blue print reading; and financial systems.

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