Staff Engineer – Advanced Operations

Stryker

. Lead the development, optimization, and control of upstream and downstream biologics manufacturing processes across internal and supplier operations .

Posted 9/15/2026full-timeMahwah • New Jersey • United StatesLead💰 $89,300 - $178,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biologics manufacturing processes, including development, optimization, and validation, while ensuring compliance with FDA and ISO 13485 regulations. Proficient in technical documentation generation and mentoring engineering teams to enhance process robustness and efficiency.

Highest-signal resume keywords

Biologics ManufacturingProcess DevelopmentValidation MethodologiesStatistical AnalysisTechnical Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process CharacterizationEquipment QualificationDesign For Manufacturing (DFM)Geometric Dimensioning And Tolerancing (GD&T)Measurement System Analysis (MSA)Capability StudiesValidation ProtocolsControl PlansPFMEAsSOPs

Soft Skills

MentoringTechnical GuidanceStakeholder Communication

Industry Keywords

FDA-RegulatedISO 13485Regulated ManufacturingNew Product Introduction (NPI)Global Supply Chains

About the role

Key responsibilities & impact

Lead the development, optimization, and control of upstream and downstream biologics manufacturing processes across internal and supplier operations
Conduct process characterization, variability, hold-time, and worst-case condition studies to establish process robustness and define in-process control strategies
Evaluate, select, and qualify manufacturing equipment and components based on technical specifications, reliability requirements, and applicable regulations
Support equipment installation and validation activities
Generate and review technical documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation to support product launches
Mentor engineers and provide technical guidance across multiple product portfolios
Deliver technical updates and recommendations to stakeholders and leadership
Support New Product Introduction (NPI) and biologics process development across process design, validation, manufacturing readiness, and supplier collaboration

Requirements

What you’ll need

Bachelor’s degree in Mechanical Engineering or a related engineering discipline
Minimum 7 years of engineering experience in manufacturing, process development, product development, or a related field
Minimum 7 years of experience supporting regulated manufacturing environments
Experience developing and validating manufacturing processes, including statistical analysis and verification/validation methodologies
Experience interpreting engineering drawings, specifications, and geometric dimensioning and tolerancing (GD&T)
Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA)
Preferred: Experience supporting biologics manufacturing or biologics process development
Preferred: Experience in FDA-regulated or ISO 13485-regulated industries and supporting complex global supply chains

Benefits

Comp & perks

Hybrid or onsite work flexibility
20% travel opportunity/coverage
Equal opportunity employment protections
Pay transparency and pay discussion protections