Product Quality Engineer | Medical
The Product Quality Engineer must have at least 10 yrs. experience in medical device quality and program management. Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met. Must be capable of directing teams across many organizational areas including design, engineering, tooling, quality, manufacturing, and sales.
Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.
Responsible for fostering a technical relationship with the customer to encourage additional sales through future product development areas, and facilitate the overall sales cycle.
Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
Ability to manage direct reports with varying technical and engineering backgrounds required.
Duties and Responsibilities
- Manage/Coordinate team of engineers and technical staff.
- Manage Programs: Including Technology, Metrology and Cross Functional Teams from Manufacturing, Engineering, Quality and other internal/external resources.
- Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met.
- Provide leadership to technical teams responsible for successful launch of multiple complex programs.
- Service and grow our program base within the Medical / Life Science Industry (Technical Sales)
- Responsible for overseeing the coordination and on-time/in-budget completion of all projects which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes. Oversee all aspects of programs beginning at customer order through to successful transfer to Manufacturing.
- Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
- Ability to participate in product design (R&D) meetings with Medical Customers in relationship with Weiss-Aug Manufacturing technologies.
- Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
- Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
- Oversee the development and input of initial BOM and detailed Routing
- Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
- Jointly responsible for successful transfer of tooling to Manufacturing along with Toolroom and Design Engineering functions.
- Oversee the selection and management of key suppliers as required by project. Oversee the completion of requisitions for approval by management for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications.
- Assist in determining needs for additional personnel and/or training in order to meet program needs.
- Identify and facilitate new and/or special equipment needs along with Manufacturing Engineering.
- Manage program risks by considering tradeoffs between time, cost, customer needs and product and manufacturing physics.
- Interface with customer on technical and schedule-related issues. Ensure program progress is communicated to customer at regular intervals.
- Mediate conflicts between departments. Forge compromise and consensus between team members.
- Assist in identifying areas for continued improvement and opportunities to gain organizational knowledge.
- Participate in customer, internal and registrar quality system audits.
- Support Sales and New Product Development Teams. May assist in identifying potential leads and opportunities.
- Minimum of 10 yrs. experience in quality and program management. Experience in medical device/life science industry required.
- Experience with management of direct reports and technical staff.
- Experience with product design, program/project management, and understanding of tight-tolerance manufactured products is required.
- Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
- Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
- Ability to use SolidWorks for product/tooling design preferable.
- Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
- Knowledge of GMP/ISO Quality Systems required.
- Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
- Knowledge of progressive metal stamping and/or insert molding processes desirable.
- Participate actively in a team-oriented environment. Provide leadership to cross-functional teams whenever necessary with ability to lead in all areas of a manufacturing organization.
- Ability to support Technical Sales and grow our program/customer base in the Medical Industry.
- Proficient in Microsoft Project. Able to create Gantt charts including: creation and linking of tasks, assigning of resources, tracking of tasks, and progress reporting.
- Proficient in Microsoft Word, Excel, and Powerpoint.
- Knowledge or MRP or ERP software preferable.
- Exceptional analytical and computational skills. Knowledge of problem-solving tools and techniques preferable.
- Excellent verbal and written communication skills.
- Demonstrated high level of negotiation and conflict-resolution skills.
- Demonstrated high level of creativity and innovation.
- Demonstrated decision-making capability.
- Demonstrated customer interfacing skills, including “soft skills” needed to facilitate technical sales.
We provide excellent company benefits and a competitive salary. We are an equal opportunity employer. Currently only accepting local candidate submissions.