Packaging Engineer II - Exempt

Join our team in North Haven, CT, a vibrant community known for its rich history and proximity to major cities. We are seeking a dedicated professional to take on a critical role in our packaging engineering team.

This person will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. They will be responsible for process development activities and creating the validation plans in compliance with company standards. They will be the project lead and communicate project deliverables and timing to engineering management.

Must Have:

• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with Minitab)

Other Skills:

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices

Nice to Have:

• 1-3 years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team

Top 3 Technical Skills Required:

• Packaging Experience
• Validation Experience – Process Development, OQ, IQ, PQ
• Familiarity with Cognex and Keyence based vision inspection systems

Education and Experience:

• BS (or above) Engineering Degree; Mechanical, Manufacturing, Packaging
• 3-5 years of relevant experience

Work Schedule:

Full-time, 40 hours per week. Required to be onsite full-time.

Responsibilities:

Responsibilities may include the following and other duties may be assigned:

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing, and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Specialist Career Stream:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors:

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience:

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.