Danaher Corporation Manager, Injection Molding and Tooling Engineering in Sunnyvale, California
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
NOTE: This position can be remotely based from anywhere in the USA.
Lead a team of professional tooling/injection molding engineers and report to the Director of Component and Tooling Engineering. The incumbent will demonstrate an expertise in the design & development of consumable polymer components, mold design and tooling with expertise within the injection molding processes for medical device manufacturing.
The position will demand a multi-layered, broad perspective to identify & drive innovative solutions to sophisticated challenges that enable efficient manufacturing for sustainable, large-scale injection molded production at several different manufacturing locations World-Wide.
Use their knowledge of mechanical design, thermoplastic materials, injection molding tooling, metrology, and systematic processing approaches to engineer custom solutions, lead DFM reviews, improve current designs, collaborate withNPI vendors, and enable usage of next generation technology for consumable plastic components.
They will use their experience in all phases of a product lifecycle to transition designs from the initial concept phase (prototyping) through Design and Development (small scale feasibility) and into Production (NPI). Through these phase gates of product development. Drive D/PFMECA, DFM, and CAE tools to develop robust part and tooling designs. This technological approach will enhance manufacturing efficiencies for injection molding through finished device assembly.
This is very much a hands-on position involving detailed design (3D modeling and 2D print specifications), testing, prototype fabrication and engineering support of Production; work/co-ordinate with other engineers/teams, scientists and operations personnel teams (at Cepheid); While building robust relationships with external vendors and suppliers.
Essential job responsibilities:
Advance existing consumables parts production, with an emphasis on refining processing requirements, defining tooling concepts, proposing methodologies that use World Class technology for medical component manufacturing, while maintaining integral product quality and performance.
Lead part design, tooling component, subassembly, and complete assembly specifications in SolidWorks ePDM and Quality Management System (QMS). Ensure those specifications are applicable to product function and Cepheid's Quality Policy and associated standards.
Use CAD & 3D moldex modeling, prototyping, molding simulation CAE data, and hands-on testing to drive molding technology, process robustness, and technical feasibility assessments of new tooling concepts.
Design, test, and validate new consumable designs and tooling concepts in collaboration with multi-disciplined engineering teams.
Proactively identify risks in of parts design, molds, and methods associated with injection molded consumables. Leads multifaceted corrective and preventative actions.
Lead specification, sourcing, project management, and/or acceptance (FAT/SAT) of injection molding projects to support global manufacturing facilities or the design development center.
Work with manufacturing facility engineering & management to find opportunities for automation and robotics to reduce cost and improve quality, with a focus on flexible automation that can be used across multiple customer programs.
Lead teams to objectively utilize statistical, process data, DOE, and root cause analyses to tackle sophisticated injection molding and process challenges such that robust performance at high manufacturing efficiencies is enabled. Ability to exercise judgment based on analysis of multiple sources of information.
Establish working relationships with vendors for outsourcing of engineering services, materials supply, injection molding tool design, and contract manufacturing of consumables components.
Ability to drive internal/external functional teams or projects with high risk, resource requirements, and/or complexity
Ability to prioritize and lead multiple, concurrent projects in a fast-paced environment. Works independently, with guidance in only the most sophisticated situations.
Interprets internal/external business challenges and recommends standard methodologies to improve products, processes, or services.
Coordinate Engineering testing, first article inspections, and qualification activities.
Mentor others to utilize advanced inspection technologies, statistical methods, DOE, process data, and root cause analyses to identify required improvements to injection molding tools, processes, and measurement techniques such that high manufacturing performance efficiencies is achieved.
Write verification and validation protocols and related technical reports to support part/mold new production introduction (NPI).
Work with Qualification Team to go through molding process development and complete injection tooling press and mold IOQ.
Provide technical feedback for justification in the reduction of molded part cost of goods
Resolve impact of part and process changes as they relate to Cepheid business plan.
Develop high standards for all Consumables products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.
Finish the assigned and required training on time
For people managers, ensure your associates attend and finish the required trainings satisfactorily and on time.
Education and Experience (in years):
Bachelor’s degree with 9+ years of experience OR
Master’s degree with 7+ years of experience
Knowledge and skills:
Excellent verbal and written communication skills.
Solid understanding of GMP, ISO, and FDA rules and regulatory requirements.
Confirmed experience with large-scale injection molding.
Expertise in plastics material properties, molding process development, and tooling design.
. Ability to communicate sophisticated concepts and negotiates with others to build to adopt an alternative point of view.
Proficiency with SolidWorks, Minitab, and Microsoft Office applications.
RJG certification or equivalent plastics industry formal training is strongly desired.
Experience with creating drawings, BOMs, product specifications, and engineering drawings.
Domestic and international travel up to 25%. Heavy US and Intl Travel monthly
Must have or be able to get a current passport.
BSc in Mechanical, Plastics, Manufacturing or Chemical Engineering or equivalent combination of education and experience to perform at this level (9+ years of relevant experience).
MSc preferred, in an engineering field (7+ years of relevant experience).
Project management experience, PMP certificate or equivalent.
Quality Management System experience preferred.
Extensive knowledge in GD&T, metrology, and statistical tolerance stack-up analysis
Experience in computer-aided engineering analysis software (i.e. Sigmetrix CETOL, Autodesk Moldflow, ANSYS, etc.)
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid