Sr Packaging Engineer - Exempt

LanceSoft Inc

North Haven, CT

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Analysis Skills, Biotech and Pharmaceutical, Coaching, Cross-Functional, Document Management, GMP (Good Manufacturing Practices), Gap Analysis, ISO (International Organization for Standardization), Industry Standards, Interpersonal Skills, Laboratory Analysis, Laboratory Testing, Leadership, Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Medical Products, Mentoring, Microsoft Office, People Management, Printing, Process Improvement, Process Management, Product Costing, Product Packaging, Project Design, Project Tracking, Project/Program Management, Prototyping, Quality Assurance Methodology, Quality Engineering, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Sales, System Validation, Systems Analysis, Talent Management, Technical Drawing, Technical Writing, Test Plan/Schedule, Testing

LOCATION

North Haven, CT

POSTED

30+ days ago

Location: Hybrid - 3 days in either North Haven, CT office or Lafayette, CO office. Please confirm location on candidate resume. Top 3 Technical Skills Required: Leads successful validations of packaging systems for medical devices. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2. Lead project meetings and provide updates to management. Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering, or similar discipline. Years of Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging. Work Schedule: 40 hours per week, Hybrid - onsite 3 days per week (North Haven, CT or Lafayette, CO). Interview Timeline: ASAP Product Line Supported: Various within Surgical OU The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following: Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2. Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation. Leads successful validation of packaging systems for medical devices. Identify and develop innovative packaging processes and designs as part of a cross-functional team. Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required. Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses, and provide innovative ideas to ensure compliance to latest industry practices. Lead project meetings and provide updates to management. Assist in labeling development process. May perform and evaluate testing in a laboratory environment as per industry standards. Minimum Requirements: Bachelor of Science Degree in Packaging Science, Mechanical Engineering, or similar discipline. Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering. Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience. Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required. Established and productive individual contributor with strong team and interpersonal skills. Knowledge of Microsoft Office programs is required. CAD/CAPE/TOPS Software knowledge is preferred. Responsibilities may include designing, developing, and testing 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 external variables such as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering factors like product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may also 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 projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Differentiating Factors: Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching, and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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