Astrix · 3 hours ago
Process Development Engineer (medical device)
Rahway, NJ
Full-time
Onsite
Senior Level
$110K/yr - $135K/yr
7+ years expAstrix is a growing medical device manufacturer near Clark, NJ, seeking a Process Development Engineer to support the launch of new manufacturing capabilities. The role involves developing and optimizing manufacturing processes, creating programs and SOPs, and ensuring successful production transitions.
ConsultingInformation Technology
Responsibilities
Lead development and implementation of manufacturing processes for new and existing products
Develop programs, procedures, and SOPs for new equipment, including a recently installed needle grinding machine
Collaborate with cross-functional teams to develop robust manufacturing and inspection methods
Oversee process development projects from concept through production handoff
Work directly with external vendors and equipment suppliers on setup, optimization, and troubleshooting
Communicate project timelines, risks, and requirements across engineering, operations, and leadership teams
Partner with manufacturing and quality engineers to ensure smooth process transfer into production
Lead or support process qualification and validation activities, including:
First Article Inspections
OQ / PQ validations
PFMEA
Control Plans
Measurement System Analysis (MSA)
PPAP activities as required
Conduct process characterization and statistical analysis to improve quality, efficiency, and cost performance
Provide ongoing production support and drive continuous improvement initiatives
Manage multiple projects while meeting budget and timeline expectations
Support vendor audits or customer collaboration efforts as needed
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Engineering or related technical field
7–15 years of process or manufacturing engineering experience
Strong process development and internal project management experience
Excellent communication, analytical, and organizational skills
Ability to manage multiple priorities in a fast-paced environment
High attention to detail and commitment to quality
Self-starter capable of working independently
Preferred
Medical device or other highly regulated manufacturing experience
Contract manufacturing experience
Experience working with custom CNC or automated manufacturing equipment
Experience collaborating with external vendors on equipment/process development
Experience supporting capital equipment implementation and qualification
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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