About the position
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Responsibilities
- Design and develop best-in-class packaging solutions for sterile and non-sterile medical devices from early concept through commercialization.
- Support packaging needs from early concept through to end-of-life.
- Design packaging solutions that meet both internal and external customer needs.
- Own all aspects of design verification of the packaging systems to meet design requirements and release to production.
- Collaborate with manufacturing and process engineering to implement packaging designs compatible with a class 8 clean-room environment.
- Identify new packaging processes to improve efficiencies and reduce costs.
- Develop component specifications, inspection plans and packaging protocols/reports to ensure that the packaging system performs to requirements.
- Create and manage change requests within the document control system.
- Support qualification of sealing/packaging processes within clean room.
- Manage all projects to ensure that all internal and external packaging compliance requirements have been met and that the product is not on the critical path for launch.
- Set standards within the organization for the packaging requirements needed for ISI products.
- As packaging SME, support audits, non-conformances and CAPAs as needed.
Requirements
- Minimum BS Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field.
- At least 8+ years of experience in medical device packaging design development and various packaging processes (high volume preferred).
- Has a proven background in packaging dynamics lab equipment, including electrodynamic/ hydraulic vibration equipment, environmental chambers, shock testers, compression testers, drop testers and monitored drop testing.
- Thorough working knowledge of packaging dynamics, various packaging materials, and their compatibility with sterilization processes such as, but not limited to EtO and Gamma.
- Knowledge of packaging validation and verification requirements under CFR Part 820, ISO11607 part 1 & 2 and applicable ASTM standards. Proven understanding of GMP.
- Proven design and project management skills and ability to manage multiple reusable and/or single-use disposable (SUD) packaging projects across multiple product lines on time.
- Excellent verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate at multiple levels in the organization.
- Demonstrate a high level of service while managing a high and varied workload from internal clients and adhering to tight timelines.
- Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment.
- CAD knowledge and experience (Pro-E or Solidworks, ArtiosCAD) preferred.
- Must be able to travel occasionally to vendors, subcontractors and ISI Mexico plant.
Benefits
- Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
