Benefits:

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Relocation bonus

Vision insurance

STAFF PACKAGING ENGINEER - HYBRID Location: Franklin Lakes, New Jersey, United States

Industry: Medical Equipment / Devices Job Category: Manufacturing - Product Development

Duties & Responsibilities:  Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products.  Technical leader of the design, development, and qualification of packaging systems for new and existing products. Independently develops and drives strategies for: o Design Development: Develops packaging designs, DOE’s, edge of failure analysis, process development and design verification. o Design for Manufacturability (DFM): Assess manufacturability, material selection, development of packaging processes for new or existing packaging systems. o Defining Packaging Requirements: Translate customers and regulatory needs into engineering requirements and specifications.  Leads multiple, complex, high-volume projects at one time.  Implement DFSS tools through the design selection and development process, deploying statistical and analytical tools.  Internal technical packaging SME and mentor for other packaging engineers

Education and Experience:  A Bachelor’s degree in Packaging, Mechanical, Materials Engineering or a related Science/Engineering field is required. A post-graduate degree (MSc or PhD) is preferred.  A minimum of 8 years of experience in packaging of medical devices, pharmaceutical and/or combination products is required.  A demonstrated track record of technical influential leadership and delivering results  Excellent oral, written, and interpersonal communication skills  Ability to tactfully advise decision-maker

Knowledge and Skills: Required  Detailed knowledge of ISO-11607-1 and -2, ISO 13485, medical device packaging ASTMs, cGMP and medical device validation methodology  Packaging systems, medical device class II and III, design verification and validation experience for primary, secondary and tertiary; flexible and rigid packaging applications  Experience with different medical device package designs (i.e. FFS pouch, top lid rigid trays, pre-made pouches, etc)  Proficiency using solid modeling tools (SolidWorks preferred)  Proven experience on forming and sealing packaging processes  Experience using design for six sigma (DFSS) elements for packaging systems design and/or analysis  Statistical analysis using Minitab software (i.e. DOE, process capability, analysis of variances)  Understanding of sterilization technologies (i.e. radiation and gas) and their impact on medical device packaging  Proven expertise on technical critical thinking interpreting data results, demonstrating equivalency and/or technical rationales for medical device packaging design systems  Proven experience following medical device design control

Preferred  Experience on DOT, IATA and IMDG regulations for the shipment of hazardous materials  V&V experience for drug containers  Proven expertise in finite element analysis  Proven use of engineering first principles analysis  Container closure USP standard & WHO guidelines

Flexible work from home options available.