Astrix · 20 hours ago
Process Development Engineer
Rahway, NJ
Full-time
Onsite
Mid, Senior Level
$110K/yr - $135K/yr
7+ years expAstrix is seeking a Process Development Engineer responsible for developing, qualifying, and transferring robust manufacturing processes for new and existing products. The role involves collaboration with cross-functional teams and oversight of process development projects from concept through production handoff.
ConsultingInformation Technology
Responsibilities
Develop, optimize, and qualify manufacturing and inspection processes for new and existing products
Review and interpret product functional and design specifications
Lead and provide oversight for process development projects from concept through production handoff
Collaborate with cross-functional teams, including operations, quality, manufacturing, and engineering, to ensure robust process design and execution
Coordinate with external vendors and contract manufacturers to ensure alignment on requirements, timelines, and quality expectations
Communicate project timelines, requirements, and status to internal teams, customers, and senior management
Ensure resource needs are identified and supported in collaboration with operational and quality leadership
Lead process validation and qualification activities, ensuring compliance with internal, customer, and regulatory requirements
Perform process characterization, SPC analysis, and continuous improvement activities to meet quality and cost targets
Support vendor audits, root cause analysis, and customer alignment activities, including occasional travel
Manage multiple projects within design specifications, timelines, and budget constraints
Qualification
Required
Bachelor's degree (B.S.) in Engineering or a related technical field
7–15 years of experience in process development or manufacturing engineering
Experience in a highly regulated industry; medical device experience preferred
Experience with contract manufacturing and external vendor management
Proven experience leading large-scale projects involving CAPEX, process development, and extensive qualification requirements
Strong understanding of manufacturing process development, validation, and qualification methodologies
Working knowledge of PFMEA, Control Plans, MSA, SPC, PPAP, OQ/PQ, and First Article Inspections
Strong project planning, organizational, analytical, and problem-solving skills
Preferred
Experience in a highly regulated industry; medical device experience preferred
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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