Senior Manufacturing and Process Engineer

Job overview

The Senior Manufacturing and Process Engineer role is onsite in Westminster, CO. The posting lists annual compensation of $115,000–$125,000. The role supports manufacturing and process engineering for medical device products at TriSalus Life Sciences. The engineer leads process technology development, validation, and improvement across product lines, helping move products from development into manufacturing while maintaining quality-system compliance. The work also improves yield, cycle time, scrap, cost, and production capability through validation, risk management, process controls, and cross-functional project leadership.

What you'll do

• Lead development, validation, and improvement of manufacturing processes and technologies
• serve as a senior technical resource across product lines
• lead projects from concept through commercialization, including product introductions and transfers
• develop and validate processes and equipment and execute IQ/OQ/PQ and test method validations
• maintain the process validation master plan
• apply DOE, SPC, MSA, and capability analysis
• lead process risk management and PFMEAs
• provide design-for-manufacturability input
• reduce cycle time, scrap, and cost
• qualify tools and production systems
• monitor yield and corrective actions
• perform cleanroom validations as required
• support vendor and contract manufacturer activities
• lead nonconformance investigations and CAPA
• author and approve quality documentation
• train operators and technicians.

What we're looking for

Skills & competencies

senior manufacturing engineer

process engineer

trisalus life sciences

westminster co

onsite

$115,000–$125,000/year

medical devices

process validation

iq/oq/pq

fda 21 cfr part 820

iso 13485

doe

spc

capa

cleanroom

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in Mechanical or Biomedical Engineering or a related scientific discipline, at least 10 years of medical device manufacturing experience, FDA-regulated experience, and process validation experience. Requires knowledge of FDA 21 CFR Part 820, ISO 13485, statistical methods, design controls, risk management, and CAPA.

About the employer

Trisalus Life Sciences, Inc. is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.