Senior Engineer

Job Title: Senior Engineer
Location: Medina, NY
Duration: 12 months

Senior Engineer

Summary: Applies a solid understanding of engineering and problem-solving theories/practices toward the development of new or enhanced products or processes. Creates service deliverables and infrastructure required to support initial product launch and lifecycle management. Capable of designing machine tooling, jigs, fixtures, gauges and equipment used in the servicing process. Capable of checking designs and drawings against general standards, design requirements, geometric tolerances, drafting practices and the manufacturing process involved. The work of the individual should be highly creative, of high quality and offer wide latitude for independent judgment and perception with a minimal amount of supervision.

Essential Duties & Responsibilities:
1. Creates new product development and lifecycle management service deliverables throughout the product lifecycle for medical device products involving hardware.
2. Supports new product platform releases. Develops and implements service training, test equipment, tools, spare parts, and service manuals / instructions.
3. Evaluates / makes recommendations on product releases related to design for serviceability. Creates (or modifies existing) servicing processes and manuals to support repair or refurbishment of fielded product at multiple global sites or in the field.
4. Works closely with design team to select, develop, and implement technologies across all medical device development programs.
5. Analyzes key servicing metrics to identify and implement opportunities for improvement in service process quality, cost, or product reliability.
6. Coordinates information flow between corporate and local/regional teams.
7. Owns Corrective and Preventive Actions related to the product(s) core team(s) supported, using sound root cause analysis.
8. May represent Technical Services on new product development and/or lifecycle management core teams.
9. May independently plan, schedule and lead cross-functional teams in detailed phases of the engineering work in a project.
10. May approve the work of lower level engineers; may supervise other engineers or technicians

Minimum qualifications:
1. Must be well versed in core engineering disciplines (e.g. mechanical, electrical, software, systems engineering).
2. Highly motivated self-starter who is able to work with minimal supervision.
3. Must have good interpersonal and oral/written communication skills, good time management, and be capable of analyzing and solving technical problems through innovative thought and application of sound engineering principles and root cause analysis.
4. Experience with change control methodologies and configuration management principles is a plus.
5. Experience with test engineering and/or reliability engineering principles is a plus.
6. Ability to exercise independent judgment and draw conclusions based on available information.
7. Good understanding of GMP and quality system requirements.
8. Must have the ability to travel.

Education and/or Experience:

Bachelor's degree in a core engineering discipline (mechanical, electrical, software, systems, or mfg/process engineering) plus 3-5 years of experience. Medical device experience or other regulated industry experience preferred. Experience in the use of Lean Six Sigma tools highly desirable.