Job Description
Advanced Engineering and Technical Services –
West Region Package Development – Santa Rosa
Reports to:
Manager, Package Development Engineering
Position Description
- Responsible for the design and development of new package systems for sterile medical devices
- Responsible for ensuring medical device packaging meets or exceeds requirements for end user functionality, safety, manufacturability, sustainability and business and program objectives
- Through collaboration with health care providers, internal cross functional groups, program management and packaging team members, establishes design requirements, and performance and business criteria.
- Will work as the lead package engineer development packaging and collaborating with R&D, operations, suppliers, and others, to design, develop, validate and integrate package systems into operations.
Position Responsibilities
- Identifies and prioritizes opportunities to create significant end user, patient and business value through packaging and drives implementation of those opportunities
- Leads package design activities, collecting voice of customer to identify packaging functionality that assists medical teams in the performance of a therapy.
- Develops and implements designs and processes that optimize manufacturability and barrier performance while lowering cost and risk.
- Develops package concepts, creates prototypes, plans and executes feasibility and design characterization studies.
- Responsible for requirements flow (customer voices into needs into design targets) and then leads effort to gain management approval and funding.
- Provides technical guidance to more junior packaging engineering team members including root cause failure analysis, testing method development, material selection, design and solid modeling assistance, and prototyping
- Provides project management support to packaging engineering team members including relationship building with internal cross functional teams, supplier selection, use of design and manufacturing methodologies, risk analysis and mitigation plans, plus project oversight as needed.
- Leads strategic initiatives within the packaging team with focus on best practices, stake holder value, quality, and cost effectiveness, standard work, and design and technical rigor
- Utilize knowledge of FDA, ISO, and EN requirements related to packaging and labeling.
Basic Qualifications
- 4-7 years of relevant experience with a BS BioMedical, Mechanical, Industrial, Manufacturing, Packaging or related engineering field; 2 years with an advanced degree
- Medical device packaging, R&D, manufacturing or field technical support experience
- 2-3 years use of mechanical design (SolidWorks, PTC or other), statistical analysis (MatLab, MiniTab or other)
- Knowledgeable in ISO, ASTM, ISTA standards and test methods related to packaging
- Experience with terminally sterilized package design, materials, sealing methods, operating room procedures and sterilization methods.
- Solid proficiency in MS applications
- Familiarity with FDA and EU quality assurance requirements for design and manufacturing
- Ability to travel up to 15%, both domestic and international
Preferred Qualifications
- 2-3 years experience with trans-catheter therapies and related devices
- Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology
- Experience with Design Verification and Process Validation
- Use of FEA and prototyping techniques
Additional Qualifying Criteria
- Certified Packaging Professional (CPP) preferred
- Project Management Professional (PMP) certification
- Lean Six-Sigma Green or Black belt certification