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Form of workLife 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 Packaging Engineer with positive, engagement and collaborative energy to join our team and support the continued growth of the New Hampshire Facility.
The Packaging Engineer's primary role is to execute the development and technical transfer of medical device packaging projects, including packaging component design and testing/validation, as well as facilitating the integration of new packaging components into Production. The Packaging Engineer shall work closely with customer representatives in the packaging development and coordinating the successful execution of project/program deliverables through the LSO Project Manager. In addition, Packaging Engineer shall work closely with Production and Quality Assurance team members to ensure packages are designed for repeatability and reliability through the manufacturing process.
Essential Duties and Responsibilities include the following. NOTE: Other duties may be assigned.
- Conceive, design and develop packaging components and systems for medical device and/or delivery systems in accordance with customer/product specifications and quality system requirements. Converts customer needs into new product concept solutions;
- Works with vendors and customers to identify appropriate materials and components to meet packaging requirements;
- Design, order and procure components; develops prototypes of concepts and subcomponent mechanisms;
- Designs and develops tooling and fixturing required to support new products and line extensions; recommends appropriate packaging equipment to meet packaging design and material requirements.
- Conduct engineering analysis and feasibility testing of packaging components/systems to ensure proper fit and function. Key point of contact with Packaging Test Lab partners to perform Package Performance Qualifications; utilizes design concepts and analysis techniques, including but not limited to:
- Failure Mode Analysis
- Finite Element Analysis & modeling
- Geometric Dimensioning
- Statistical Analysis
- Tolerancing Analysis
- Stress/Strain Analysis
- Transportation Analysis (Packaging)
- Partner with Quality and Regulatory to conduct risk analysis and develop/execute design verification and validation activities to relevant packaging standards (IQ/OQ/PQ);
- Partner with Manufacturing to develop assembly procedures;
- Actively participates on New Product Development teams and Design Reviews;
- Maintain relationships with vendors to understand new technology development.
- BS degree in Packaging or other Engineering discipline;
- 5+ years of experience relating to labeling and packaging within the medical industry (ISO 13485) is a must
- Expertise with Solidworks™ and other applicable packaging design/modeling software platforms;
- Experience relating to GDP and GMP and Quality Management Systems;
- Hands-on approach to problem solving, risk identification and resolution;
- Excellent Microsoft Office skills (Word, Excel, Project)
- Ability to work on multiple projects simultaneously/ adjust workload based upon priorities;
- Effective analytical skills with demonstrated success in problem solving;
- Secondary process experience including plastic manufacturing/thermoforming, foil/blister dispense/sealing, automation controls and hardware highly desirable;
- Hands on experience with process development and validation of sterile barrier heat sealing processes for Form/Fill/Seal, Pouch, and Tray/Lid Flows;
- Familiarity with performance of medical packaging formats and materials as relates to the sterilization process (gamma, EtO, E-Beam, etc.);
- Familiarity with heat seal tooling design and associated process development and validation.
Skills and Abilities
- Good interpersonal skills with demonstrated ability to function successfully in team environment; able to lead/collaborate with team members and gain buy-in through effective communication and team-oriented problem solving;
- Effective listening and good communication skills (verbal/written), ability to issue clear instructions;
- Good problem solving and conflict resolution skills;
- Ability to comprehend and retain working knowledge of complete product line;
- Ability to multi-task and respond to changing priorities;
- Ability to promote and encourage process improvement initiatives to department staff;
- Ability to assess and incorporate end-user needs related to Aseptic Transfer in package designs.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Individual will need to sit (at times for extended periods) or stand as needed. May require walking primarily on a level surface during the workday. Reaching above shoulder heights, below the waist or lifting as required to move materials and equipment during the workday. Ability to lift up to 50 pounds using proper lifting techniques.
Work Environment
The work environment is that found in a light production, warehousing, shipping setting with primarily overhead lighting. The facility is temperature controlled, and the air quality is good. At times, individual will need to transition in and out of "clean room" production portion of space.
