Life Science Outsourcing, Inc. · 8 hours ago
Sr. Manufacturing Engineer
Life Science Outsourcing, Inc. is a company focused on improving manufacturing systems in the life sciences sector. The Sr. Manufacturing Engineer will design, integrate, and enhance manufacturing processes while collaborating with customers to refine product designs and manage projects to streamline operations.
Industrial EngineeringManufacturingMedical DeviceProduct Design
Responsibilities
Design, integrate, and improve manufacturing systems and related processes
Collaborate with customers and designers to refine product designs, enhancing manufacturability and reducing costs
Manage projects using project management tools, leading efforts to streamline manufacturing processes for new products and engineering initiatives
Apply lean principles and advanced manufacturing technologies to drive efficiency and minimize waste
Spearhead automation initiatives to optimize manufacturing processes, and other critical packaging operations
Oversee and execute the validation and optimization of equipment for medical device manufacturing, ensuring compliance with industry standards for manufacturing, packaging integrity, seal strength, and sterile barrier maintenance
Qualification
Required
Bachelor's degree in Engineering or related
7 years of experience in Manufacturing Engineering experience in a regulated industry (e.g., medical devices, pharmaceuticals, aerospace)
2 years of experience managing multiple products or projects
Expertise in the following regulated industries, medical devices, pharmaceuticals, or aerospace, ensuring familiarity with industry-specific standards and regulatory requirements
In-depth knowledge of lean manufacturing, Six Sigma, and process improvement methodologies
Proficient in ISO 13485 standards and related quality management systems
Experience with cleanroom environments and standards
Experience in manufacturing a diverse range of medical devices, including implants, orthopedic devices, and packaging
Experience with precision assemblies
Experience with sterilization processes, including autoclave and other common methods for medical devices
Knowledge of ultrasonic cleaning and other medical device cleaning techniques
Proficiency with PFMA (Process Failure Modes and Effects Analysis), DFMA (Design for Manufacturing and Assembly) and GD&T (Geometric Dimensioning and Tolerancing)
Proficiency creating Routings, BOMS (Bill of Materials) and Labor Standards calculation and definition
Proficiency in ERP (Enterprise Resource Planning) systems for managing production workflows and materials planning
Proficiency in CAD/CAM systems (e.g., SolidWorks) and machining principles for tooling design, and assembly, including building and design of tools, jigs, fixtures, and specialized equipment to support efficient and accurate manufacturing and assembly processes
Proficiency in project management and using tools (e.g., Asana or equivalent) to oversee new product introduction (NPI) and complex engineering projects
Experience with operating and maintaining manufacturing and testing equipment, including vision systems, ultrasonic cleaners, UV and 3D printers, and pouch sealing machines
Expertise in Process and equipment validation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
Experience with packaging validation for medical devices
Experience with Lucid chart for process mapping
Experience in prototype development, R&D designs, and full product transfers, including Design for Manufacturing (DFM) transfers
Proficiency in Minitab for statistical analysis and process controls
Benefits
Standard benefits apply.
Company
Life Science Outsourcing, Inc.
Life Science Outsourcing is a performance-driven Contract Manufacturing Organization.
H1B Sponsorship
Life Science Outsourcing, Inc. 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 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-01-05Acquired
Recent News
Medical Product Outsourcing
2025-10-24
Mergers & Acquisitions
2025-10-21
Company data provided by crunchbase