Process Dev Engineer

Overview

On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Able to Provide Sponsorship

Skills

Bachelors degree or higher in Engineering (Biomedical; Chemical; Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.Experience
Minimum 5 years in medical device; IVD or regulated manufacturing roles
Experience with microfluidics; surface chemistry; reagent formulation or cartridge production preferred
Proficiency in DOE; SPC and statistical tools (e.g. JMP; Minitab)
Prior experience authoring and managing production documentation in ERP systems (e.g. SAP)

Job Details

Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as pre-packaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.

We are currently looking for ' Process Dev Engineer' to support one of our clients with the following skills:

Requirement:

Role: Process Dev Engineer

Location: Santa Clara, CA (100% Onsite Position)

Duration: 12+ months

Travel Requirements

Estimated Amount: 10%

Brief Description: Domestic and international travel based on business needs.

Description:

As a member of the client Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. The role operates within a matrix organization, collaborating with cross-functional and multinational teams to ensure compliance, process capability, and product supply integrity.

Responsibilities

Technical Support:

Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives.

Conduct product and process characterization, including capability studies and identification of critical parameters.

Author and maintain Work Instructions and other production-related documentation in compliance with quality standards.

Design and implement In-Process Controls (IPCs) to monitor CTQs during manufacturing.

Develop and maintain CTQ-Scorecards to track performance against quality attributes.

Lead or support root cause investigations using structured methodologies (e.g., Kepner- Tregoe, 5 Whys, Fishbone Analysis).

Partner with cross-functional teams for specification development, process characterization, and material qualification.

Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.Continuous and Process Improvement:

Lead strategic improvement initiatives targeting cost reduction, yield improvement, and process efficiency.

Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA).

Collaborate across the client network to share and implement best practices.

Quality Mindset:

Ensure compliance with Quality System requirements through document control, change management, and monitoring.

Participate in and support audits, CAPAs, NCRs, and validation of methods and systems.

Other duties as assigned by management.

QUALIFICATIONS

Formal Training/Education

Bachelor s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.Experience

Minimum 5 years in medical device, IVD, or regulated manufacturing roles.

Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.

Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).

Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).

Knowledge, Skills and Abilities

Strong communication, collaboration, and influencing skills across all levels.

Ability to independently manage technical tasks and projects with minimal supervision.

Demonstrated experience implementing in-process controls and CTQ metrics.

Familiarity with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.

Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).

The national base pay range below is a good-faith estimate of what our client may pay for new hires. Actual pay may vary based on Client's assessment of the candidates knowledge, skills, abilities (KSAs), related experience, education, certifications and ability to meet required minimum job qualifications. Other factors impacting pay include prevailing wages in the work location and internal equity. $130,000 - $140,000

Note: Please send your updated resumes to sureshs(at)tranzeal(dot)(com)

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.