About the Role
As the Manufacturing Technician, you will perform all in-house manufacturing and remanufacturing operations, including product assembly and test. You’ll be responsible for assembly and testing both durable and disposable products.
To Make an Impact, You Will:
- Perform all in-house manufacturing and remanufacturing operations using documentation as released within the Quality Management System (QMS) in compliance with cGMP.
- 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.
- 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.
- 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 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:
- Four (4) years minimum of direct functional experience in a medical device environment preferred.
- Medical device in electromechanical and electronics experience required.
- Some technical knowledge of assembly and test of electronic equipment including software application/program.
- High School diploma or equivalent required
- 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.
