Instant Systems Inc. · 10 hours ago
Process Engineer
Norfolk, VA
Full-time
Onsite
Senior Level
5+ years expInstant Systems Inc. is seeking a highly motivated and detail-oriented Process Engineer to join their team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single-use supplies, including medical device components.
BiotechnologyManufacturingMedical Device
Responsibilities
Develop, implement, and optimize manufacturing processes
Troubleshoots and resolves hardware manufacturing, quality and test issues to support production schedules
Provide corrective actions to fix tooling to minimize downtimes
Conduct process validation activities including writing and executing IQ/OQ/PQ Improves manufacturing processes, documentation, yield and test efficiency in collaboration with a multi-disciplined team
Translates engineering design requirements into manufacturing operations sheets, work instructions, tooling and test equipment, workflows and processes
Design, develop, and implement new manufacturing equipment, fixtures, and tools to enhance production capabilities
Dispositions non-conforming material with root cause, corrective action and defect analysis as required to prevent recurrence
Reviews design drawings for manufacturability and cost (DFM, DFC)
Analyze production data to identify trends, inefficiencies, and opportunities for improvement
Collaborate with cross-functional teams to support new product introductions and process scale-up
Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies
Troubleshoot process issues and conduct root cause analysis and corrective/preventive actions (CAPA)
Support equipment selection, installation, and qualification
Maintain and update process documentation including SOPs, work instructions, and risk assessments
Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements
Train production staff on new processes, equipment, and best practices
Monitor and improve process yields, cycle times, and overall equipment effectiveness (OEE)
Participate in audits and inspections, providing technical support and documentation as needed
Evaluate and implement automation solutions to improve process reliability and reduce labor costs
Manage small to medium-scale engineering projects from concept through execution
Other responsibilities as assigned
Qualification
Required
a Bachelor's degree in STEM
a minimum of 5 years of relevant work experience within the medical device or other regulated manufacturing environment
Strong multidisciplined engineering aptitude, analytical skills and problem-solving skills
Experience with Lean Manufacturing and Continuous Improvement activities
Proficiency with CAD modeling tools
Strong organization skills with the ability to manage multiple tasks simultaneously
Proficient use of Microsoft Office suite (Excel, PowerPoint, Word)
strong knowledge of lean manufacturing, Six Sigma, and statistical process control (SPC)
experience with validation protocols (IQ/OQ/PQ) and risk management tools (FMEA)
solid company-centric ideology
creative problem-solving skills
core values of honesty and respect
a thirst for learning
the desire to be challenged
Benefits
401K
Health Benefits: Medical, Dental, Vision
Wellness Program
Life Insurance
Corporate Sponsored Events
Skill growth opportunities
Short Term Disability
Ability to Advance
Working with energetic & creative problem solvers
A mission worthy of your energy and expertise
Company
Instant Systems Inc.
Instant Systems produces single use supplies, packaging and specialized kits for the rapidly advancing biotechnology sector; specifically in the areas of cell-based assay/culturing, tissue engineering/regeneration, biopharmaceuticals and fermentation.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tara Ramsey
President & CEO
Uzair R.
Chief Operating Officer
Company data provided by crunchbase