Senior Manufacturing Process Engineer - Injection Molding
San Jose, CA
Engineering /
Full-time /
On-site
About Visby
Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
The Senior Manufacturing Engineer, Injection Molding will provide technical and strategic leadership of the Visby Medical Injection Molding engineering activities. Develop strategy and lead teams to execute Injection Molding category plans that ensure technical sustainability of quality component supply, at scale, across Visby Medical. This includes establishing Engineering standards and best practices for category areas, developing and/or selecting appropriate technologies and processes, and being responsible for supplier technical evaluation, partner selection, component and technology validation, transfer, and integration, as well as identifying supply risks, mitigations and business impact in concert with cross-functional teams from global Operations and New Product Development sites.
How You’ll Make an Impact
- Work closely with external and internal quality teams to ensure materials meet the required standards and specifications, are free of molding defects and will not negatively affect automation OEE.
- Identify injection molding tooling risk, developing mitigation strategies, best practices, alternative solutions. Resolve molding related issues in collaboration with cross functional teams.
- Collaborate with suppliers to establish strong relationships and monitor performance to ensure high-quality, consistent materials supply.
- Identify areas for quality and process improvement and lead initiatives to enhance supplier quality, efficiency, and minimize waste. Execute improvement projects both externally and internally.
- Analyze automation OEE historical and live data to identify and select continuous improvement activities with most ROI.
- Collaborate with quality, supply chain, procurement, manufacturing, R&D, and other departments to align activities with company objectives. Main four production manufacturing objectives in order of importance are: scrap reduction, labor cost reduction, productivity improvement, and BOM cost reduction.
- Solve critical supply quality and continuity problems with supplier SMEs, including troubleshooting at the vendor site.
- Implement product and process improvement projects to make manufacturing assembly processes more robust and reliable with Six Sigma and Lean practices and tools.
- Ensure the appropriate implementation of quality control, DFM/DFA, design for cost, mistake proofing, to minimize patient and regulatory compliance risks.
- Establish and apply a global scorecard and performance management process to ensure robust execution of category strategy, projects, and supply chain risk mitigation. Establish program level plans, scorecards, and performance management process es to ensure deliverables are completed in a timely and effective manner.
- Perform other duties and responsibilities as assigned.
On Your First Day We’d Like You to Have
- Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial) or a related field. Master's degree is a plus.
- 4+ years experience in injection molding technology development, product requirements development, and injection molding manufacturing processes development and qualification is required.
- Injection mold tooling design and fabrication experience with both domestic and international partners.
It’s Great If You Have
- Strong mechanical aptitude with a working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
- Critical-to-automation dimension and molding experience beyond critical-to-quality attributes.
- Knowledge of quality assurance and regulatory requirements in the medical industry is a plus.
- Excellent project management skills with a track record of delivering component sourcing projects on time and within budget.
- Demonstrated application of data analysis and statistical tools in manufacturing.
- Ability to identify and resolve molding processing issues in real time at the supplier’s facility with supplier SMEs.
- Lean Six Sigma black or green belt
$140,000 - $160,000 a year
(Salary range for candidates based in San Jose, CA)
Compensation for the role is based on geographical location.
Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.
More about our benefits
Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.
Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.
Additional information
We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.
