Senior Process Engineer, Advanced Manufacturing Engineering
Overview
Lead development and scaling of joining and welding processes for complex medical devices. Drive process optimization and innovation in a regulated environment. Optimize manufacturing efficiency and quality. Scale production while maintaining compliance.
What You'll Do23
- 1Design, develop, and qualify robust joining and welding processes, including laser welding, resistance welding, and micro-welding, for new and existing products.
- 2Lead process development and improvement initiatives using DMAIC principles to improve yield, throughput, and process capability.
- 3Own critical welding process documentation, including control plans, work instructions, and validation protocols.
- 4Collaborate with cross-functional team members and operations to align process development with product and business objectives.
- 5Transfer welding and joining processes from development to production, ensuring smooth ramp-up and operator training.
- 6Plan and execute validation work, collect and analyze data, and prepare compliant validation reports.
- 7Characterize and optimize welding parameters through DOE, capability studies, and statistical tools.
- 8Work with equipment vendors on specification, selection, installation, and qualification of welding equipment and automated cells.
- 9Recommend equipment and process modifications to meet quality standards and improve production yields.
- 10Integrate equipment and material capabilities to meet process module specifications.
- 11Review product development requirements to determine manufacturing feasibility and cost.
- 12Interact with product design teams to ensure manufacturability and compatibility of designs and processes.
- 13Conduct statistical analyses of process performance and update documentation based on data-driven insights.
- 14Lead innovation and optimization of new manufacturing concepts, processes, and procedures.
- 15Oversee tooling, fixture, and equipment installation and assess process inputs and outputs.
- 16Develop manufacturing processes suitable for statistical process control and establish measurement systems.
- 17Support nonconformance investigations and CAPA activities related to welding processes.
- 18Ensure compliance with ISO standards and FDA expectations for quality and regulatory requirements.
- 19Provide technical and sustaining engineering support, addressing day-to-day process issues.
- 20Formulate, deliver, and manage assigned projects with stakeholders to achieve objectives.
- 21Communicate effectively with internal and external stakeholders to exchange information and influence decisions.
- 22Guide, coach, and mentor lower-level professionals while directing project work and reviewing deliverables.
- 23Contribute to a culture of continuous improvement, safety, and operational excellence.
Requirements15
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons experience in advanced manufacturing engineering
- 3Bachelor’s degree in Engineering or related field
- 4Hands-on experience with laser welding, resistance welding, or micro-joining
- 5Proven ability to apply DMAIC, root cause analysis, and statistical tools
- 6Experience interpreting engineering drawings and translating them into manufacturing processes
- 7Strong collaboration with cross-functional teams in regulated environments
- 8Familiarity with ISO standards, FDA QSR, and GMP
- 9Prior experience in medical device, pharmaceutical, automotive, aerospace, or nuclear industries
- 10Experience with laser systems, welding equipment, or automated joining cells
- 11Knowledge of design for manufacturability (DFM), DOE, and Minitab
- 12Exposure to Lean, Six Sigma, or continuous improvement programs
- 13Ability to lead projects, mentor staff, and manage stakeholder relationships
- 14Understanding of project management principles and effective communication
- 15Professional background meeting Actalent's eligibility requirements
Salary Insight
$40 - $65k per year
Location
Required Skills
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