Responsible for leading and supervising a team of highly skilled mechanical engineers and designers as they provide technical solutions to address our customers challenging medical device development programs. These programs include complex electromechanical systems from mobile health devices to implantables.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Perform lead engineering role as sole engineer or as part of a team.
• Recruit and maintain staff. Resources projects with employees, independent contractors, and temporary contractors.
• Mentors/coaches staff. Develops and leads staff to establish and maintain excellence in technical expertise.
• Sets work direction and oversees engineering work. Assists with overcoming roadblocks.
• Works hand in hand with staff, Program Managers and customers to ensure optimal and sound engineering solutions are implemented within budget and schedule.
• Keep abreast of regulations, standards and provide training to staff and others.
• Responsible for identification, purchase, training, and maintenance of tools and equipment.
• Support internal groups across the organization.
• Establishes and maintains processes/procedures. Ensures policies and process is followed. Effectively creates and supports process enhancement initiatives.
• Observes safety and security procedures, including maintaining confidentially, using equipment / materials properly, reporting potentially unsafe conditions, and acting upon appropriate actions.
To perform the job successfully, an individual should demonstrate the following competencies:
• Achievement Focus – Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; recognizes and acts on opportunities; takes calculated risks to accomplish goals.
• Communications – Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
• Managing Customer Focus – Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction; develops new approaches to meeting customer needs.
• Managing People – Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates’ activities; makes self-available to staff; provides regular performance feedback; develops subordinates’ skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services; continually works to improve supervisory skills.
• Planning and Organization – Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
Directly supervises employees. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Bachelor of Science degree in science related field, and minimum of 7+ years of experience with demonstrated success in Medical Product Development including minimum 3 years in a leadership role. Knowledge of medical device Regulations (examples: 21 CFR, ISO 13485, ISO 14971, ISO 9001, etc.). Comprehensive knowledge of mechanical engineering in a regulated field is a must.
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