Must be U.S. Citizen
We are searching for a Mechanical Engineer supporting Cepheid’s molecular diagnostics instrument platform in the Hardware Systems Engineering group. Our team needs your broad base experience in sustaining engineering to expand the capabilities of Cepheid’s Sustaining engineering team. You will be relied upon as a key hands-on interdisciplinary specialist in a fast-paced team that is sustaining current bestselling generation instrumentation. This is a role within the Mechanical team, which is part of larger team comprised of mechanical, electrical and optical engineers passionate about the common goal of developing and commercializing Cepheid’s world impacting molecular diagnostic platforms. Successful candidate will have strong technical skills in Mechanical Engineering. He/she will have demonstrated leadership in driving teams to implement product improvements with a focus on product reliability.
Essential Job Responsibilities
- Maintain and/or improve existing products to achieve better quality and/or cost reductions. Coordinate with vendors to optimize Design for Manufacturability (DFM).
- Experienced knowledge of Mechanical Design tools (SolidWorks and Solidworks PDM .).
- Experienced planning, tracking, reporting out, and leading resources to meet project work you’re doing.
- Knowledge in machining & similar fabrication techniques, CNC machining experience.
- Demonstrated process subject area and documentation practices to assure functionality, safety, reliability and quality of the product.
- Write and release Engineering Change Orders (ECOs) for engineering drawings and Bills of Material (BOMs)
- Fast learner, self-motivated, willing to work outside the job description.
- Ability to work well with timelines participate in multiple projects, and meet timeframes.
- Must demonstrate leadership skill, drive, and self-initiative to deliver clear business outcome. Lead and mentor team members while driving activities within and across functional groups.
- Provide recommendations for investigation direction and/or countermeasures.
- Recommend and implement improvements to current design, procedures, and process.
- Strong verbal and written communication skills. Knowledge and skills.
- Most meaningfully, the associate should exhibit the desire and ability to collaborate and excel in teamwork and communication, as well as work independently without mentorship.
Education and Experience (in years):
- Master’s degree in Mechanical Engineering with 2+ years of experience OR
- PhD degree in ME with 1+ yrs. of experience.
- Experience in working in diagnostics, medical device, life sciences, or biotechnology industry
- Experience in confirmed, hands-on mechanical design/integration for commercial instrumentation/consumer products.
- Experience in project management
Knowledge & Skills
- Excellent leadership, interpersonal and communication skills (oral and written).
- Technical background in mechanical engineering fundamentals.
- Solid understanding of a Product Lifecycle Management (PLM) system.
- Work multi-functionally, seek and resolve component obsolescence and end of life issues.
- Knowledge of manufacturing processes (including soft and hard tooling, machining, injection molding, wire EDM, electro polishing, brazing, heat treatment etc).
- Experience in contract manufacturer product transfer, and medical/Biotech industry.
- Excellent writing and documentation skills.
- Experience in the use of process improvement and Lean methodologies such as Kaizen, Kanban, 5S, poke-yoke, and value stream mapping useful
- Proficient in SolidWork, FEA, CFD, MS Office
- Experience with design of experiments (DoE)
- Experience with NPI process, and Design Control process
- Experience of medical regulatory process
- Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations
- Experience with root cause analysis techniques and documentation of results
- Experience in Agile methodology