Medical Device – Packaging Engineer
Job Description
Who We Are
Network Partners is a decentralized professional services provider whose purpose focuses on the support functions necessary to enable medical device, pharmaceutical and biotechnology products to be marketed globally. Network Partners launched in 2015 by assembling top industry experts and has grown to over 250 team members in 2021. We were named to the INC. 5000 list of fastest growing private companies for the past two years. We operate in our core competency areas of packaging engineering, regulatory affairs, labeling, quality and project management. www.networkpartners.com
Our Mission:
The world is suffering. Our clients are racing to get patients the products they need. Network Partners is assembling and deploying inspired professionals to advance the industry, so people live healthier, more vibrant lives.
Your Role
Do you want to take control of your career? Have you envisioned becoming part of an inspired professional team, where package engineering is celebrated?
At Network Partners we encourage career development, life-work balance, and knowledge sharing. As a member of the Network Partners’ team of inspired professionals, you will be supporting EUMDR initiatives for a best in class medical device manufacturer.
The packaging engineering role is on-site in Denver Colorado. Your role will utilize your medical device packaging expertise to help our client meet their program objectives.
Join Network Partners today and support the Lifesciences industry helping to bring lifesaving products to market, while growing your career.
Your Team
Network Partners’ is a business of inspired professionals who are driven, possess high emotional intelligence and a growth mindset for continuous learning and generosity of spirit. You will have growth opportunities supporting our clients, as well as our Network Partners packaging team. Joining Network Partners packaging, you will be supported by our knowledge bench™, our team of industry experts.
You will be an integral team member of our packaging engineering business as well as be on site with your client team.
Responsibilities
- Provide subject matter expertise to cross functional teams.
- Generate packaging gap analysis’s against EUMDR packaging regulations.
- Generate comprehensive strategy to resolves gaps.
- Execute to the clients EUDMR strategy.
- Coordinate and manage testing activities with contract laboratories.
- Design and develop best in class packaging solutions from early concept through commercialization for sterile medical devices.
- Execute to process validation deliverables.
- Demonstrate development of life cycle knowledge through delivery of design control deliverables.
- Provide subject matter expertise to cross functional teams.
- Build Quality into all aspects packaging deliverables.
About You
Your experience and technical competencies:
- Demonstrated experience in medical device, biotech, or pharmaceutical packaging design development desired.
- Demonstrated experience in resolving design and process related packaging issues on commercial products.
- Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (11607, ASTM, ISTA)
- Experienced in Statistical Analysis, interpretation, and communication of results.
- Excellent interpersonal and communication skills.
- Strong technical and project management capabilities.
- Working knowledge and application of industry standards, including testing methods—ASTM and ISTA and relevant ISO standards
- Working knowledge and understanding of packaging testing equipment, for example, transit testing equipment, universal test system for seal strength testing, leak testing equipment
- Highly motivated with good collaboration skills
- Curious, with a continuous learner mindset and motivation to effectively problem solve
- Ability to adapt quickly and execute, especially when gaps are identified
Your Qualifications
- Bachelor’s degree in packaging engineering.
- 3-7 years expertise in medical device packaging engineering role.
- Knowledge of packaging components and packaging systems from a design, development, and qualification perspective.
- Experience operating within a quality management system.
- Experience in packaging design, development, and process validation.
- Knowledgeable in ISO 11607 regulations and ASTM and ISTA test methods.