Project Engineer

Life Science Outsourcing, Inc. (“LSO”) (www.lso-inc.com) is a contract manufacturing organization focused on assembly, packaging, sterilization, and packaging with over 25 years of experience. The Company serves orthopedic, cardiovascular, diagnostic, dental and a variety of other medical specialties. Our unique model is focused on in-house end-to-end portfolio processes and service offerings with deep regulatory knowledge. This provides the agility and flexibility that customers need to accelerate their go-to-market launches while standardizing their supply chain and mitigating risk. Clients rely on LSO to perform all activities required to introduce their products to market, from procurement to final packaging and shipping.

LSO’s is headquartered in Brea, CA (North Orange County). In January 2023, the Company added its east coast facility in Somersworth, New Hampshire (formerly J-Pac Medical).

We are currently seeking a self-motivated Project Engineer  with positive engagement and collaborative energy to join our team and support the continued growth of the New Hampshire Facility. The Project Engineer is responsible for leading, managing, and executing medical device manufacturing and product development projects. This position is responsible for ensuring projects are delivered on time, within scope, and aligned with company objectives while maintaining strict adherence to FDA Quality System Regulations and ISO 13485 standards.

We encourage you to submit a resume with salary requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Lead and manage all aspects of new product development (NPD) and manufacturing transfer projects for medical device programs, from initiation through production.
• Perform Hands on design of LSO products and tooling, utilizing tools such as CAD (SolidWorks), 3D printing software and equipment, manual machining, hand tools, etc.
• Serve as the primary liaison between internal stakeholders and customers, ensuring alignment on strategy, deliverables, and timelines.
• Develop and maintain comprehensive project documentation including schedules, budgets, resource plans, and risk assessments.
• Coordinate cross-functional activities between R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain.
• Oversee the startup of new customer production lines, including procedure development, line clearance, and operator training.
• Provide hands-on support and training for manufacturing processes and quality systems (FDA QSR, ISO 13485).
• Ensure Work Orders and manufacturing documentation are accurately completed and conform to work instructions.
• Support validation activities including but not limited to IQ/OQ/PQ/PPQ, Test Method Validations (TMV), and Process Characterization.
• Champion continuous improvement efforts in project execution, documentation, and quality systems.
• Communicate project status, milestones, risks, and mitigation plans to internal and external stakeholders, including executive leadership.
• Mentor junior engineers and support the development of team capabilities in project management and engineering best practices.
• Interface with suppliers to resolve issues, identify opportunities, and drive performance improvements.
• Identify cost-saving opportunities through process improvement, automation, and lean manufacturing initiatives.
• Contribute to the development and maintenance of work instructions, standard operating procedures, and training materials.
• Ensure compliance with environmental, health, and safety (EHS) requirements and support a culture of safety.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related engineering discipline.
• Minimum of 7 years of experience in regulated medical device manufacturing or product development.
• Proven project and/or program management experience with increasing levels of complexity.
• Proficient in Microsoft Office Suite and project management tools.
• Proficient in Solidworks and other Design technology solutions.
• Strong documentation, organizational, and communication skills.
• Knowledge of FDA regulations, ISO 13485, and GMP requirements.
• Knowledge of manufacturing processes commonly used in medical device assembly & sterile barrier packaging
• Thermoforming
• Thermal & Ultrasonic Sealing
• Labeling & Packaging

Demonstrate a sense of ownership and pride of craftmanship in one’s own work

Hands on, roll-up-the-sleeves attitude

Preferred Qualifications:

• Project Management Professional (PMP) or similar certification.
• Experience in Class I/II/III medical device manufacturing.
• Experience working with executive stakeholders and cross-functional teams.
• Experience working in a small, impactful team environment
• Startup environment

Experience and familiarity with automated and manual machining & manufacturing processes

• 3-axis mill, lathes, other common machine shop equipment
• Familiarity with enterprise-wide initiatives or system implementations.
• Ability to influence without authority and navigate competing priorities in a fast-paced environment.