Danaher Corporation Tooling Engineer in Sunnyvale, California
The successful candidate will have expanded knowledge and practical experience in the design and development of tooling concepts for consumable plastic components for medical device manufacturing. Investigates and evaluates existing technology, current capabilities, and product requirements to develop tooling specifications that enable efficient manufacturing for sustainable, large-scale consumables production (>30MM units annually). The successful candidate must be able to use their knowledge of mechanical design, thermoplastic materials, injection molding tooling, and systematic processing approaches to engineer custom solutions, develop DFM feedback, improve current designs, interface with vendors, and enable usage of best in class technology for consumable plastic components. They will use their experience in all phases of a product lifecycle to transition designs from the concept phase (prototyping) through Design and Development (small scale feasibility) and into Production (new product introduction). Through these phase gates of product development and/or new product introduction, the successful candidate will apply D/PFMECA, DFM, and CAE tools to develop robust tooling designs that encourage manufacturing efficiencies for injection molding through finished device assembly. This is a hands-on position involving detailed design (3D modeling and 2D print specifications), testing, prototype fabrication and engineering support of Production; must be able to interface well with other engineers, scientists, vendors, and operations personnel. There are no direct reports to this position.
ESSENTIAL JOB RESPONSIBILITIES:
Maintain and/or improve existing consumables parts production, with an emphasis on refining tooling specifications, proposing tooling concepts that leverage best in class technology for medical component manufacturing, and maintaining integral product quality and performance.
Manage tooling component, subassembly, and complete assembly specifications in SolidWorks ePDM and Quality Management System (QMS) and ensure those specifications are applicable to product function and Cepheid's Quality Policy and associated standards.
Use CAD modeling, prototyping, molding simulation CAE data, and hands-on testing to develop and enhance molding technology, process robustness, and analyzes technical feasibility assessments of new tooling concepts.
Design, test, and validate new tooling concepts in collaboration with multi-disciplined engineering teams.
Proactively identify risks in the design of parts, molds, and methods associated with injection molded consumables. Leads multifaceted corrective and preventative actions.
Enforce high standards for all consumables products such that technical issues are resolved and continuous improvement is relentlessly pursued.
Objectively utilize statistical methods, process data, DOE, and root cause analyses to solve complex injection molding and process challenges such that robust performance at high manufacturing efficiencies is enabled. Ability to exercise judgement based on analysis of multiple sources of information
Write verification and validation protocols and related technical reports to support new tool builds, with ability to articulate statement of work itemization to both internal and external parties.
Actively participate, interface with, and coordinate with cross functional teams consisting of internal and external parties as a technical point person. Those parties may include external suppliers and internal Engineering and Operations departments.
Acts as a resource for colleagues with less experience. Ability to lead small projects with manageable risk and resource requirements.
Ability to prioritize and manage multiple, concurrent projects in a fast-paced environment. Works independently, receives minimal guidance.
Has knowledge business best practices and how their role integrates with others.
Provide technical input for justification in the reduction of molded part cost of goods
Determine impact of part and process changes as they relate to Cepheid business plan.
Coach other engineers in plastic injection molding and tooling, as a subject matter expert.
BS in Mechanical, Plastics, or Manufacturing Engineering or equivalent combination of education and experience to perform at this level.
Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
Proven experience with large-scale injection molding with a minimum of 5+ years of direct related experience.
In-depth knowledge of plastics material properties, molding process development, and tooling design.
Excellent verbal and written communication skills. Ability to articulate difficult and/or sensitive information; works to build consensus.
Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
Experience with creating drawings, BOMs, product specifications, and engineering drawings.
Project management experience would be a plus, PMP certificate or equivalent.
Quality Management System experience preferred.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Operating Company: Cepheid