About the Role
The Sr. Manufacturing Technician, New Product Introduction (NPI) will be responsible for performing, transferring, and training manufacturing operations, including the assembly and testing of disposable products. The role will collaborate with cross-functional teams in R&D, Quality and Operations to ensure manufacturing processes are established, documented and executed in accordance with regulatory requirements.
To Make an Impact, You Will:
- Perform manufacturing operations using documentation as released within the Quality Management System (QMS) in compliance with cGMP.
- Assist Engineering with prototype build to effectively transition product cycle from Development to NPI to Manufacturing.
- Assist in new product transfer of manufacturing to contract manufacturer including training of staff.
- Train and assist manufacturing personnel at contract manufacturing facility
- Contribute in hands-on definition of MPIs, WIs, TPs and DHRs.
- Identify and support ECO changes required and work with manufacturing engineering for its implementation.
- Provide support in manufacturing products for animal lab studies including execution of design verification and validation activities.
- Provide assistance in materials logistics and quality such as receiving, receiving inspection, stocking and kitting of work orders for in-house or outside manufacturing.
- Perform activities required to process RMA’s and administrative field returns.
- Contribute to operations initiatives to continually improve quality, reduce cost, reduce cycle time and simplify processes.
- Assist in future facilities expansion activities & facilities maintenance.
- Ensure compliance with company policies, procedures, and regulatory.
To Excel, You Will Bring:
- High School diploma or equivalent required.
- Minimum 5+ years of hands-on experience with prototyping, NPI or direct manufacturing in a medical device environment.
- Catheter development and production experience required.
- Experience soldering small components under a microscope preferred.
- Some technical knowledge of assembly and test of electronic equipment including software application/program preferred.
- Proficient knowledge and skill in Microsoft Office Suite applications.
- Excellent oral and written communication skills with critical thinking skills.
- Understands cGMP & ISO job related regulations.
- Highly organized, detailed oriented, and the ability to be flexible taking on many different tasks.
- Strong analytical, interpersonal and communication skills.
- Ability to establish and maintain good working relationships with all functional areas.
- Experience in a fast-paced start up environment.
- Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Ability to lift 10-15 pounds.
