Medical Device, Production/Manufacturing Manager

Pentax Medical • Montvale, NJ • 1d ago

About PENTAX Medical

Our?mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.

Position Opening: ? Manager, Production/Manufacturing

Why JOIN Us?

We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.??

PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.??

Want More INFO?

The Manager of Production/Manufacturing is responsible for overseeing the activities for the ENT Manufacturing facility. This means hands on development of manufacturing set up and production of our life enhancing ENT product-line. While managing a core technical team of 8, this person will provide manufacturing expertise to Engineering and QARA teams on projects and issues. Provides senior level support and personal contributions to projects, processes, CAPA resolutions, and other requested tasks as required.is responsible for overseeing the activities within the ENT Production function.

Responsibilities of Manager, Production/Manufacturing

Lead, plan, manage, and coordinate activities within the ENT Production Department

Ensure processes are developed to support the company objectives, while ensuring local, state, federal, and FDA compliance

Determine areas for potential improvement and cost effectiveness in business operations relating to scheduling, workflows, and team management

Monitor, control and reduce costs of operation through regular waste elimination and daily management for improvement

Evaluate production efficiencies, variances, and procedures on a continuous basis for process improvement

Manage all work commitments with production personnel in order to maintain customer demands and minimize downtime for an efficient production flow

Provide guidance to staff in technical and management issues

Strategically plan activities that will grow engagement of the production team including activities such as regular talent reviews, periodic feedback and encouraging individual development plans

Serve as a key member on the Sustaining Engineering Team guiding and ensuring that ENT products and their manufacturing processes are successfully sustained in the event of components, OEM parts or accessories becoming unavailable or notification of the end of life, design change or other impacts to delivery

Support R&D projects, such as new product development, process development, process qualification and design transfer, as the operations member of the cross functional team by leading and performing tasks within the project that is required

Serve as the chair of the Materials Review Board (MRB), providing senior level guidance and decisions for disposition of NCRs and production issues.

Support Quality Regulatory and CAPA projects as the operations member of the cross functional team by leading and performing tasks within the project that is required

Serve on the CAPA Review Board, to address, correct and resolve production and quality related correction and preventive actions and issues.

Supports facilities manager, which may include personnel, align facility related projects with landlord, issue building maintenance work orders, assess building and grounds for safety

Ensure staff performs work in compliance with procedures and with the required personal safety equipment and trainings

Assist in the development and formal review of product assembly work instructions prior to implementation. Participate in effective communication with cross functional teams for better alignment

Requirements of Medical Device, Senior Quality Engineer:

Bachelor's Degree or equivalent experience. Engineering or Operations Management

Minimum of 5 years of experience in managing production in a regulated environment

Ability to be hands on with manufacturing when needed

Excellent communication and interpersonal skills

Experience with motivating a team and providing conflict resolution

Demonstrated ability to lead change while improving employee engagement

Exceptional attention to service, detail, and quality

Familiarity with PENTAX Medical products and services a plus

Exposure to facilities management a plus

It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.

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