Essential Functions:- Lead the sterile barrier packaging design and development for Musculo-skeletal implants.
- Provide guidance on process validation activities (for both new packaging configurations and packaging production lines).
- Develop and adhere to the framework for packaging design and development based on a product development process
- Lead and support supplier- and site-initiated material device and packaging component changes.
- Perform transportation studies to confirm that the designed packaging and device configuration protects the finished Medical Devices during various phases of the supply chain cycle.
- Coordinate root cause investigations and provide solutions using problem solving skills to improve manufacturing reliability & compliance
- Maintain a partnership with various stakeholders, other manufacturing sites and suppliers for changes to packaging and device components.
- Provide mentorship to mid-level engineers on various aspects of packaging engineering
QualificationsEducation:- Bachelor degree in a technical field: Engineering, Science, or biomedical engineering. Master degree in Science is a plus.
- Other relevant fields of study are accepted and will be considered.
Experience and Skills:Required:- 7-10 years oven experience in a Medical device (or equivalent regulated) packaging engineering design and development environment.
- Working knowledge of ISO 11607 (parts 1 & 2) standards. Ability to apply the standard to various project scenarios to come up with best possible outcomes.
- Understanding of medical device design controls per the ISO 13485 standard.
- Working knowledge of the full suite of ASTM tests for medical device packaging verification and validation.
- 2+ years of experience in working at a packaging engineering test lab.
- Strong interpersonal and communication skills in English to be able to effectively collaborate with operators and both global and local colleagues
- Ability to work independently and as part of a team.
- Strong analytical skills
Our Values:Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
- Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
- Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
- Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
- Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
