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Process Development Engineer

Santa Clara, CA 95050

Posted: 05/07/2025 Job Number: 74627 Pay Rate: $65 - $70

Job Description


Contract Process Development Engineer
Onsite | Local Candidates Preferred
Hourly Rate: $65–$70/hr

Join a dynamic Manufacturing Sciences and Technology (MSAT) team supporting cutting-edge sequencing technology. We're seeking a Process Development Engineer for a contract role focused on enhancing manufacturing performance, product quality, and process efficiency in consumables and cartridge production.

This role is a key link between product development and manufacturing operations—ideal for engineers who thrive in cross-functional environments and want to make a tangible impact on product delivery and quality.

What You’ll Do
Technical & Operational Support

  • Provide direct, hands-on support to troubleshoot and optimize manufacturing processes.

  • Conduct process and product characterization to identify and control critical parameters.

  • Author and maintain manufacturing documentation, including Work Instructions, in compliance with quality standards.

  • Design and implement In-Process Controls (IPCs) to track Critical-to-Quality (CTQ) attributes.

  • Create and maintain CTQ Scorecards for ongoing performance monitoring.

  • Lead or assist with structured root cause investigations using methodologies like 5 Whys, Fishbone Analysis, and Kepner-Tregoe.

  • Collaborate with cross-functional teams to define specifications, qualify materials, and characterize processes.

  • Design and execute experiments using statistical tools such as JMP or Minitab.

Continuous Improvement

  • Drive initiatives focused on cost savings, improved yields, and overall process enhancement.

  • Apply Lean Six Sigma principles to streamline operations and reduce variability.

  • Keep process risk documentation (e.g., pFMEA) current and accurate.

  • Share best practices and solutions with partner teams across the organization.

Quality & Compliance

  • Support Quality System compliance through effective change control, document management, and process monitoring.

  • Participate in audits, corrective/preventive actions (CAPAs), non-conformance reports (NCRs), and method validations.

  • Champion a quality-first mindset throughout the production lifecycle.

What You Bring
Education & Experience

  • Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or a related technical field. Equivalent experience considered.

  • Minimum 5 years of experience in medical device, in-vitro diagnostics (IVD), or other regulated manufacturing environments.

  • Experience with microfluidics, reagent formulation, surface chemistry, or cartridge manufacturing is highly desirable.

  • Demonstrated proficiency in statistical process control (SPC), DOE, and data analysis using JMP or Minitab.

  • Familiarity with ERP systems (e.g., SAP) for documentation and change management.

Skills & Competencies

  • Strong interpersonal skills with the ability to communicate and influence across teams and levels.

  • Self-starter capable of managing technical challenges and projects with minimal supervision.

  • Proven ability to implement and manage CTQ metrics and in-process controls.

  • Hands-on knowledge of root cause analysis techniques (e.g., 5 Whys, Fishbone, Kepner-Tregoe).

  • Understanding of Lean and Six Sigma practices; Green Belt certification is a plus.

Preferred Certifications

  • Lean Six Sigma Green Belt certification preferred (or willingness to obtain within 12 months).

Additional Information
Work Environment:
Onsite role in a fast-paced, collaborative setting. Local candidates preferred.

Travel:
Up to 10% domestic and international travel based on business needs.


This is an exciting opportunity to work on innovative manufacturing technologies with a focus on real-world impact and operational excellence. If you’re passionate about process improvement and quality, and enjoy cross-functional collaboration, this role is for you.

EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!