Project Engineer
Project Engineer
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Job Description
Job Details
Company Description
Life Science Outsourcing Inc. (LSO) 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 inhouse endtoend portfolio processes and service offerings with deep regulatory knowledge. This provides the agility and flexibility that customers need to accelerate their gotomarket 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.
LSOs is headquartered in Brea CA (North Orange County). In January 2023 the Company added its east coast facility in Somersworth New Hampshire (formerly JPac Medical).
We are currently seeking a selfmotivatedProject Engineer with positive engagement and collaborative energy to join our team and support the continued growth of the New Hampshire Facility. TheProject Engineeris 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 SolidWorks
- 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 crossfunctional 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 handson 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 IQ/OQ/PQ/PPQ Test Method Validations (TMV) and Process Characterization.
- Champion continuous improvement efforts in project 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 costsaving 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:
- Bachelors degree in Mechanical Engineering Biomedical Engineering Materials Science 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.
Preferred Qualifications:
- Project Management Professional (PMP) or similar certification.
- Experience in Class I/II/III medical device manufacturing.
- Experience working with executive stakeholders and crossfunctional teams.
- Familiarity with enterprisewide initiatives or system implementations.
- Ability to influence without authority and navigate competing priorities in a fastpaced environment.
Required Experience:
Senior IC
Employment Type
Unclear
