Develops capable processes and ensures efficient and effective transfer of product into production.
Key Responsibilities:
Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
Prepares and presents technical data and recommendations at technical reviews.
Writes validation protocols and reports applicable to new processes.
Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
Oversees development builds associated with the project using special work requests.
Develops qualified production lines.
Provides Design for Manufacturability (DFM) input to the engineering print package.
Contributes ideas to or generates Intellectual Property submissions.
Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.
May serve as core team member or extended team member on new product projects.
Experience & Qualifications:
Level 8 degree in Mechanical Engineering or Similar Relevant Qualification required for this role.
Minimum of 3+ years experience, preferably in the medical device industry.
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem solving skills.
Strong technical capabilities and project management capability to develop aspect of assigned projects on time and within budget.