Job Details

Job Description:

Industry: Medical Equipment / Devices

Job Category: Manufacturing - Product Development

Please carefully review the position requirements before submitting a potential candidate for consideration.

The R&D Staff Packaging Engineer will impact health care and the MDS business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.

The R&D Staff Packaging Engineer contributes to building organizational effectiveness through creating, using and sharing standard processes; leading and mentoring others; seeking and providing training; driving technical and workflow innovation.

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:
  
  • Design Development: Develops packaging designs, DOE's, edge of failure analysis, process development and design verification.
  • Design for Manufacturability (DFM): Assess manufacturability, material selection, development of packaging processes for new or existing packaging systems.
  • 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

• 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

• 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

• 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