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Life Science Outsourcing, Inc.

Project Engineer

Life Science Outsourcing, Inc., Somersworth, New Hampshire, us, 03878

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Overview

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Project Engineer

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Life Science Outsourcing, Inc. We are seeking an experienced and hands-on Project Engineer to lead and execute medical device manufacturing and product development projects. This role is ideal for someone who thrives in a fast-paced environment and enjoys driving projects from concept to production while ensuring compliance with FDA QSR and ISO 13485 standards. You’ll play a key part in managing cross-functional teams, collaborating directly with clients, and championing continuous improvement across manufacturing operations. What You’ll Do

Lead and manage new product development (NPD) and manufacturing transfer projects from initiation through production. Design LSO products and tooling using SolidWorks, CAD, and 3D printing technologies. Serve as the primary liaison between internal stakeholders and customers, aligning project goals and deliverables. Develop and maintain project documentation — schedules, budgets, resource plans, and risk assessments. Oversee new customer production line startups, including procedure development, operator training, and validation activities (IQ/OQ/PQ/PPQ, TMV). Support manufacturing process improvements and ensure documentation meets FDA and ISO compliance. Lead or participate in continuous improvement initiatives and lean manufacturing efforts. Mentor junior engineers and contribute to engineering best practices. What You Bring

Bachelor’s degree in Mechanical, Biomedical, Systems, or related Engineering field. 7+ years of experience in regulated medical device manufacturing or product development. Strong project management skills with a record of delivering projects on time and within budget. Proficiency in SolidWorks, Microsoft Office, and project management tools. Deep knowledge of FDA regulations, ISO 13485, and GMP requirements. Hands-on familiarity with manufacturing processes such as Thermoforming, Thermal & Ultrasonic Sealing, and Labeling & Packaging. Excellent communication, organizational, and documentation skills. Roll-up-your-sleeves attitude with a strong sense of ownership and craftsmanship. Preferred Qualifications: PMP certification or equivalent project management credential. Experience in Class I, II, or III medical devices. Background in startup or small-team environments. Familiarity with automated and manual machining, including 3-axis mills, lathes, and general machine shop equipment. Exposure to enterprise-wide initiatives or system implementations. Ability to influence across teams and balance competing priorities. Why Join LSO

Work with a collaborative, growth-minded team bringing cutting-edge medical technologies to market. Opportunity to make a direct impact on patients’ lives through innovative device manufacturing. Competitive salary and comprehensive benefits package. A culture that values integrity, innovation, and continuous improvement. How to Apply

Ready to Bring Medical Innovations to Life? Apply today and join a company where your engineering expertise drives the future of healthcare. Visit www.lso-inc.com/careers to apply. Job Details

Location: Newington, NH Estimated salary: $75,000.00-$90,000.00

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