This is a unique opportunity to develop and lead new manufacturing AND service programs for a medical device company based in Ann Arbor.

Essential Duties and Responsibilities include the following. Other duties may be assigned.
Manufacturing:

Develops and maintains manufacturing operations business plans to include all program requirements, labor hours, cycle, production costs, and improvement programs.
Establishes production and quality control standards, develops budget and cost controls, and obtains data regarding types, quantities, specifications, and delivery dates of products ordered.

Provides guidance to the development of an outsourced manufacturing process plan, including personnel requirements, material needs, subcontract requirements, facility needs, and tooling and equipment needs.
Ensures all established costs, quality, and delivery commitments are met.
Develops and drives an aggressive multi-year cost reduction plan across suppliers and product engineering.
Coordinates manufacturing activities of contract manufacturer, internal departments and external suppliers to obtain optimum production.
Manage the development of comprehensive production documentation in conjunction with engineering.
Reviews production and operating reports and directs the resolution of operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays.
Works with Quality, Regulatory and Product Development teams to establish, measure, and assure adherence to standards for parts, processes, and finished products.
Works with Product Development teams to incorporate Design for Manufacturability into product design and outputs.
Develop logistics and processes from manufacturing transfer to system completion at outsourced manufacturer(s) to customer sites.
Schedule production and output based upon forecasts and needs with outsourced suppliers.

Service:

Develop service policies and protocols in compliance with current medical device regulations
Responsible for the complete customer satisfaction experience from delivery, installation, and service.
Develop and implement training for service technicians
Manage vendors delivering demonstration and service systems to customers.
Work with distributor service technicians to deliver service in their geographical region
Service deployment: create, lead, motivate, and manage a lean structure with protocols to deploy service at the right place and time through qualified, responsive, and accountable service partners.
Manage development of comprehensive service documentation in conjunction with Product Development teams.

Determines responsibilities of assigned organization and staff positions to accomplish business objectives.
Trains and ensures all assigned employees are aware of and comply with company, government, and customer policies, procedures, and regulations.

Competencies
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical: Synthesizes complex or diverse information; designs work flows and procedures.
Negotiate: able to work with suppliers to deliver on commitments and reduce costs. Strength and diplomacy are critical for success.
Job Knowledge: Competent in required job skills and knowledge; keeps abreast of current developments; uses resources effectively.
Requisite academic and experiential credentials in relevant technical areas, with experience in the medical device industry preferred.
Entrepreneurial spirit: ability to work in low-structure, tight-resource environment of an early stage, high-growth company.
Use of Technology: Adapts to new technologies; troubleshoots technological problems; uses technology to increase productivity; keeps technical skills up to date.
Problem Solving: Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions. Six Sigma or other current tools/methodologies is strongly preferred. Able to find solutions when things don’t go as planned.
Project Management: Develops and manages projects to plans; ability to coordinates complex projects; communicates changes, issues and progress in a timely manner.
Customer Service: Responds promptly to customer needs; solicits customer feedback to improve service; responds to requests for service and assistance; meets commitments.
Managing Customer Focus: Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction.
Teamwork: Balances team and individual responsibilities; contributes to building a positive team spirit; able to build morale and group commitments to goals and objectives.
Change Management: Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
Quality Management: Looks for ways to improve and promote quality. Experience with Customer Complaint handling in the Medical Device Industry is also preferred.
Business Acumen: Understands business implications of decisions; aligns work with strategic goals.
Ethics: Treats people with respect; keeps commitments; inspires the trust of others.

Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelor's degree from four-year college or university and 5 to 10+ years of related experience and/or training; or equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.