Director, Manufacturing and Service
Company: ENDRA Life Sciences
Location: Ann Arbor
Posted on: May 13, 2022
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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.
Manufacturing:
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.
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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.
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.
Competencies
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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