Job Description: Responsibility includes providing technical leadership in the coordination of various project activities primarily associated with internal and external manufacturing supporting new and/or revised product processing. In addition, this position is responsible for leading process improvements, quality improvements, and cost reductions related to manufacturing. This includes working with cross functional departments to provide accurate and timely resolution of issues associated with manufacturing. This position will provide leadership and support to ensure compliance with industry regulations including FDA, ISO, and OSHA guidelines.
General Functions –
o Participates in the manufacturing development for product projects that includes project scheduling, manufacturing plans, process development, and fixturing/tooling.
o Provides review of new products and/or existing product design changes for manufacturability, and inspection development including the application of appropriate GD&T.
o Defines and maintains product processing requirements while maintaining high quality and cost effective manufacturing methods.
o Works with internal/external resources for defining process activities as well as resolving processing issues.
o Creates and maintains device master routers/BOM’s
o Creates and maintains manufacturing procedures.
o Designs, coordinates fabrication, and implements process fixturing.
o Identifies, selects and/or develops appropriate inspection methods.
o Develops inspection procedures including development of the appropriate sampling plans.
o Designs, coordinates fabrication, and assigns calibration requirements for gauges and overlays.
o Develops R&R’s for inspection equipment and gauging.
o Defines, and executes equipment and processing validation activities including validation plans, installation, operational and performance qualifications.
o Develops process capability studies and analyzes data for processing methods to determine level of process controls.
o Develops technical documentation or engineering test reports.
o Participates on Material Review Board to disposition non-conformances.
o Assists in investigation and resolution of internal and supplier corrective actions.
o Analyzes and maps processes, assesses efficiency, and implements continuous improvements in various production applications.
o Applies statistical tools for quality analysis and/or departmental metrics.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA
Expected Areas of Competence (i.e. KSAs) –
Highly detail oriented; checks own work, keeps accurate records, organizes information effectively.
Excellent communication and influencing skills.
Demonstrated ability to work effectively with all levels of the organization, in a team-oriented environment.
Ability to tolerate ambiguity, handles multiple priorities, and identifies creative solutions to problems.
Demonstrated history of taking initiative, meeting commitments and assisting in the creation of new tools or solutions to achieve business results.
High level of energy, personal accountability and integrity.
Education Requirements –
Bachelor of Science degree Mechanical Engineering or equivalent.
Skill Requirements –
- Minimum five to ten (5-10) years experience (medical device preferred).
- Broad knowledge of machining, inspection methods, and metal fabrication processes.
- Ability design moderate to complex fixturing/gauging.
- Ability to validate manufacturing processes.
- Ability to interpret engineering specifications and apply Geometric Dimensioning and Tolerancing.
- Advanced computer skills including e-mail, graphics, CAD and Microsoft office.
Travel Requirements – Minimum overnight travel (up to 10%) by land or air.