Entry Level Software Developer Jobs in Wallingford, CT

Job Description:

Job Title: Packaging Engineer II
Location: North Haven, CT 06473.
Duration: 08+ months contract

Technical Skills

Must Have

1. Experience in Equipment IQ (Installation Qualification)
2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or Process Validation
3. Process Validation Lifecycle experience, including:
4. • Process Characterization
   • Operational Qualification (OQ)
   • Performance Qualification (PQ)
5. Preferred experience with DOE (Design of Experiments) using Minitab

Additional Skills

1. Computer System Validation (CSV) / Software Validation
2. SOP Development
3. Change Control for Medical Devices

Nice to Have

• 1 to 3 years of Medical Device industry experience
• Familiarity with FDA 21 CFR Part 820 and EU 2017/745 (EU MDR)
• Familiarity with:
• • 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
• Ability to work collaboratively within a cross-functional team environment

Job Description

This individual will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. The role will involve process development activities and the creation of validation plans in compliance with company standards. The individual will serve as the project lead, communicating project deliverables and timelines to Engineering Management.

Top Technical Skills Required

1. Packaging Experience
2. Validation Experience (Process Development, IQ, OQ, PQ)
3. Familiarity with Cognex and Keyence-based Vision Inspection Systems

Product Line Supported

GST Focus Factory
Responsible for validating and qualifying new nylon film used for absorbable suture products.

Key Responsibilities

Responsibilities may include, but are not limited to:

• Designing, developing, and testing a wide variety of containers used for the protection, display, and handling of products.
• Determining packaging specifications based on product characteristics, cost constraints, legal requirements, and protection needs, including resistance to:
• • Moisture
  • Corrosive chemicals
  • Temperature variations
  • Light and heat exposure
  • Rough handling
  • Tampering
• Designing package exteriors while considering:
• • Product identification
  • Sales appeal
  • Aesthetic quality
  • Printing and production techniques
• Managing documentation and/or coordinating Good Manufacturing Practices (GMPs).
• Supporting prototype line development within manufacturing facilities and plants.

Career Stream: Specialist

Typically functions as an individual contributor within a professional discipline or specialty area.

Key Expectations

• Delivers and/or manages assigned projects and collaborates with stakeholders to achieve desired results.
• May act as a mentor to colleagues or provide direction to lower-level professionals.
• Spends the majority of time overseeing projects from design through implementation while adhering to established policies and procedures.
• Applies specialized knowledge and skills typically acquired through advanced university education.

Differentiating Factors

Autonomy

• Established and productive individual contributor.
• Works independently with general supervision on larger, moderately complex projects and assignments.

Organizational Impact

• Sets objectives within their job area to meet project and assignment goals.
• Contributes to project milestone completion.
• May participate in cross-functional assignments.

Innovation and Complexity

• Addresses general problems and issues that may require understanding of broader business or functional areas.
• Recommends or implements improvements in systems and processes to enhance effectiveness.

Communication and Influence

• Communicates frequently with internal stakeholders.
• Shares information, status updates, needs, and issues to support decision-making and collaboration.
• External interactions are generally less complex in nature.

Leadership and Talent Management

• May provide guidance and support to entry-level professionals and/or employees within the Support Career Stream.

Required Knowledge and Experience

• Practical knowledge and demonstrated competence within the functional area, typically obtained through a combination of advanced education and relevant experience.
• Bachelor's Degree required; Advanced Degree preferred.