Astrix · 3 days ago
Process Engineer
Linden, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $120K/yr
10+ years expAstrix is a global leader in the medical technology world, seeking a Process Engineer to join their growing team. The role involves collaborating with validation engineers and cross-functional teams to ensure successful project launches for complex medical devices.
ConsultingInformation Technology
Hiring Manager
Emily Streb
Responsibilities
Reviews and thoroughly understand product functional and design specifications
Work with Cross Functional Team to develop robust manufacturing and inspection methods to ensure successful launch of NPI projects
Work with the NPI Validation Engineers to help prepare new large-scale projects for successful transfer into production. This includes but is not limited to
Work with Customers to ensure design requirements are understood and met
Convey project timelines and requirements to the internal team
Work with operational and quality leadership teams to ensure resource requirements are understood and met for each project
Ensure proper communication and oversight over projects in production. This can include but is not limited to
Understand customer qualification requirements and oversee execution of varying complexity. These activities could include but are not limited to
First Article Inspections, Operations Qualification (OQ), Performance Qualification (PQ), PFMEA, Control Plans, Measurement System Analysis (MSA), Customer Production Part Approval Process (PPAP)
Work with NPI Engineering team to perform process characterization studies for ensuring robust quality and/or meeting cost targets
Perform statistical process control analysis as required
Qualification
Required
Bachelor's Degree (B.S.) in a related field
10-15 years' experience
Commitment to excellence and high standards
Excellent written and oral communication skills
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Acute attention to detail
Demonstrated ability to plan and organize projects
Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization
Worked in a highly regulated industry, Medical Device experience preferred
Experience in contract manufacturing
Experience working with large scale projects that requires capex expenditure, process development and extensive qualification requirements
Experience working directly with external vendors
Experience working with a cross functional team to ensure project success
Experience working with customers to ensure understanding of project requirements and set project expectations
Preferred
PMP Certification is a plus
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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