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Director, Manufacturing and Service

Company: ENDRA Life Sciences
Location: Ann Arbor
Posted on: May 13, 2022

Job Description:

ENDRA Life Sciences (ENDRA) has a unique opportunity for someone who wants to make an impact in emerging medical technologies. We have developed a method and device for deep tissue thermoacoustic imaging that will directly address fundamental barriers to advancing the diagnostic value and expanding the use of conventional ultrasound imaging. Your manufacturing and supplier management experience will be critical to our success as we bring our products to worldwide markets.

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

With contract manufacturing partners and internally, develop and maintain manufacturing operations business plans to include all program requirements, labor hours, cycle, production costs, and improvement programs.

Establish production and quality control standards, develop budget and cost controls, and obtain data regarding types, quantities, specifications, and delivery dates of products ordered.

Provide guidance to the development of an outsourced manufacturing process plan, including personnel requirements, material needs, subcontract requirements, facility needs, and tooling and equipment needs.

Ensure all established costs, quality, and delivery commitments are met.

Develop and drives an aggressive multi-year cost reduction plan across suppliers and product engineering.

Coordinate 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.

Review production and operating reports and direct the resolution of operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays.

Work with Quality, Regulatory and Product Development teams to establish, measure, and assure adherence to standards for parts, processes, and finished products.

Work 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.


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.

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

To perform the job successfully, an individual should demonstrate the following competencies:
Analytical: Synthesize complex or diverse information; designs workflows 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 a low-structure, tight-resource environment of a late- stage, high-growth company.
Use of Technology: Adapt to new technologies; troubleshoots technological problems; uses technology to increase productivity; keeps technical skills up to date.
Problem Solving: Identify and resolve problems in a timely manner; gather and analyze information skillfully; develop alternative solutions. - Six Sigma experience or other current tools/methodologies is strongly preferred. Able to find solutions when things don't go as planned.
Project Management: Develop and manage projects to plans; ability to coordinate complex projects; communicate changes, issues and progress in a timely manner.
Customer Service: Respond promptly to customer needs; solicit customer feedback to improve service; respond to requests for service and assistance; meet commitments.
Managing Customer Focus: Promotes customer focus; establish 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: Develop 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.

Keywords: ENDRA Life Sciences, Ann Arbor , Director, Manufacturing and Service, Executive , Ann Arbor, Michigan

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