Packaging Engineer I
At CONMED, Packaging Engineers work to ensure that our diverse offering of medical device products are packaged in a way that maintains safety, quality, and sterilization. The work of our Packaging Engineers directly contributes to the accessibility and reliability of our products for our health care customers around the world.
This is an excellent opportunity for a Packaging Engineer seeking a role with accountability and a path to advance within a growing international medical device company. CONMED has multiple manufacturing and design sites across the US.
As a CONMED Packaging Engineer I, you will have accountability and responsibility for a variety of duties, including:
- Design, implement and continuously optimize packaging designs and operations processes for mechanical function, manufacturability and efficiency.
- Perform in-process packaging systems engineering tasks, such as creating new package systems to transport product during external process or intra-plant processing.
- Develop designs and create prototypes from customer concepts and/or specs to test and validate ideas.
- Identify, review, and evaluate new packaging technologies for application to current and future product design.
- Work with a diversity of manufactures to develop specifications for automated packaging equipment and support the acquisition and implementation of new packaging technologies via URS, FAT, SAT, Validation Plan, IQ, OQ and PQ processes meeting current FDA and international standards.
- Lead and/or participate in design review meetings through the Design Controls process.
- Determine packaging specifications according to the nature of the product, cost limitations, legal and regulatory requirements, considering need for resistance to such external variables as moisture, temperature variations, light, heat, rough handling and tampering. Liaison with R&D, manufacturing and supply chain personnel for the specification and sourcing of raw materials.
- Lead and manage packaging design improvement, packaging process improvement and automation projects.
- Support corporate compliance initiatives. Develop and execute remediation strategies.
- Lead packaging related CAPAs and quality improvement initiatives.
- Support EU MDR packaging remediation.
Qualifications:
- Bachelor of Science degree required. Major in Packaging Engineering, Packaging Science or a related field strongly preferred.
Preferred skills/experiences:
- Ability to use problem solving skills to improve line efficiencies on a day-to-day basis
- Knowledge of standards, Non-Conformance Report (NCR), Corrective and Preventative Actions (CAPA) and test methods used in the medical device industry preferred
- Knowledge of FDA and international standards.
- Knowledge of working in FDA regulated industry, Title 21 Part 820.
- Knowledge of ISO 13485, ISO 11607 Parts 1 and 2 requirements
- Knowledge of ISTA 3A and/or ASTM D4169 requirements
- Knowledge of packaging integrity test methods.
- Proficient with MINITAB, Basic Statistics, Optimization DOEs, Capability Analysis preferred.
- Proficient with design programs such as Solid Works, ArtiosCAD, TOPS Pro, etc.
- Fluent with Microsoft Office Programs (Project, Word, Outlook, Excel, etc.)
- Knowledge of Project Management and Microsoft Project.
Travel expectations: 10-20% as projects require.
This position is not eligible for employer-visa sponsorship.