Supports development of capable processes and ensures efficient and effective transfer of products into production. Contributes with Process Development engineers, scientists, and/or teams in the development and analysis of processes and equipment. This position requires high independence and knowledge on automated manufacturing equipment.
Key Responsibilities:
- Executes functional deliverables associated with Process Development and Technology Development projects.
- Assesses process capabilities, innovates, and implements process improvements on complex processes.
- Work with engineers and internal/external vendors to maintain/fix/calibrate/qualify manufacturing equipment.
- Support testing or manufacture of prototypes/materials with minimal engineering guidance.
- Organize and document testing data and prepare reports/documentation to communicate results.
- Applies technical knowledge to support, design, and the development of processes, procedures, tooling and automation.
- Typically makes important technical contributions as part of an extended team.
- Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing to ensure project success.
- Identifies problems and proposes solutions to technical challenges. Independently solves basic issues within functional area.
- Supports, researches, and evaluates new technologies within functional area. Remains knowledgeable of available technologies within functional area. May identify new applications for established technologies.
- Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc.
- Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively.
- Train others on new product processes and procedures.
Required Qualifications:
- Associate’s degree or equivalent combination of education/work experience
- 1-2 years of related experience
- Proven record of working closely and successfully with manufacturing and process development engineers
- Basic understanding of medical device documentation requirements
- Great attitude and strong desire to learn new skills
Preferred Qualifications:
- Manufacturing background
- Medical Device industry experience
- Good technical writing skills
- Ability to read electrical prints and schematics
Interaction and Communication:
- Demonstrates sensitivity when exchanging ideas and complex information in a concise, compelling, and logical way to internal and external stakeholders.
Quality System Requirement:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.