Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Manufacturing Engineering Manager, NPI to work with our innovative Manufacturing Engineering team in Pleasanton, CA.
Performs and coordinates a diverse range of complex activities associated with the manufacturing engineering support of existing circulatory support products, development of manufacturing processes and transfer of new products into production. Work is performed without appreciable direction. Exercises considerable latitude in determining strategic direction of a Manufacturing Engineering work group.
The Manufacturing Engineering Manager, NPI will manage projects received from internal and external customers relating to sustaining the production line, designing for manufacturability, creating new processes, validation of existing, new or external manufacturing processes and establishing manufacturing systems to drive and improve common work streams. This position will be required to lead a cross functional group of technical experts in the mechanical, electrical, chemical/process, industrial, biomedical or other engineering disciplines to provide best-in-class customer service and responsiveness in completing work. The Manufacturing Engineering manager is responsible for assuring projects are appropriately optimizing performance, scheduling and cost trade-offs. The candidate must have demonstrated ability to manage people and budgets. The candidate will operate collaboratively with Operations Management and their customers including Mfg Engineering, Production, Supply Chain, Quality, R&D, Regulatory Affairs, Customer Driven Quality and Marketing.
The candidate will represent Thoratec Corporation in a professional manner and project a quality image with the current and future internal and external customers.
The duties and responsibilities of this position include, but are not limited to, the following engineering activities:
Leads cross-functional teams and manages projects to plan with high quality deliverables. Presents data to upper management, peers as well as down the organization.
Oversees the new product introduction, sustaining, systems and or engineering service responsibilities and functions for Thoratec.
Assumes a leadership role in working with R&D project teams to transfer new products into manufacturing.
Provides technical support to manufacturing and improve productivity and reduce costs.
Provides input and support to Regulatory Affairs for FDA submission and to resolve customer concerns.
Provides project prioritization for the group. Projects will vary in duration and across a variety of disciplines, product lines and customers.
Communicates status to all projects including issues encountered, resolutions and conflicts to all levels of management.
Manages a staff of Manufacturing Engineers and/or Technicians. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Monitors productivity of direct reports and identifies means to assure efficiency and consistency of work. Periodically audits employee’s work activities to assure accuracy of work performed and compliance with GMP and regulatory requirements. Conducts performance and development discussions as needed. Engages and motivates both team and cross-functional relationships. Mentors staff to ensure future growth.
Provides guidance and performs various Engineering functions directly or through subordinates including:
Developing and validating manufacturing processes, including equipment identification, design, installation and validation for fabrication of products heavily weighted in metal precision machining and electro/mechanical assembly in a clean room environment.
Process automation, electronic data control, time flow, rework and process optimization.
Design for manufacturability and the ability to work as a part of cross-functional development teams.
Developing, releasing and maintaining product assembly drawings, bill of materials, and component drawings in an ISO-9001/FDA GMP design and document control environment.
Developing effective fabrication procedures, QA procedures, and process control documents.
Establishing manufacturing process flow diagrams and process validation procedures. Evaluating process capability and identify areas for improvement.
Collecting and analyzing “in-process” data to determine areas for process improvement. Leading process improvement projects as necessary.
Experience and knowledge in building quality into processes, including process flow and Failure Mode Effects analysis as well as gauge reproducibility and reliability.
Stays current with industry best practice and serves as a change agent to introduce effective and efficient practices to the department.
Maintains current knowledge of all applicable internal and external standards. Acts as subject matter expert when representing team in cross functional meetings or projects.
Negotiates with and supports Upper Management to allocate resources required for completing all approved projects.
Establishes , plans and operates within an annual financial budget
Promotes a strong culture of Continuous Improvement philosophies by establishing performance metrics for the group and implementing internal processes or tools to demonstrate results
Additional tasks will be assigned as appropriate.
Requires a B.S. in Mechanical, Electrical, Chemical or Biomedical Engineering.
Requires eight to twelve years engineering experience, including skills in process development, improvement and validation of a variety of equipment and process used to build a medical device (additional education may be substituted for experience).
Four years of medical device industry experience with ISO/GMP’.s
Two years experience in Managing people preferred.
Requires strong analytical, written and verbal communication skills as well as the ability to interface with all departments and manage multiple projects/deliverables.
Must have good computer software skills with word processing, database management and spreadsheets.
Experience at managing projects and presenting data to upper management, peers as well as down the organization is highly desired.
Familiarity with industry best practices and applicable standards.
WHY WORK FOR US?
For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.
Thoratec employs more than 700 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Cambridgeshire, UK; and Zurich, Switzerland.
Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.
Thoratec Corporation (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....