We design and manufacture pH and dissolved oxygen sensors for biopharmaceutical companies involved in fermentation and large scale cell culture applications. We service a worldwide customer base and provide in-depth technical support as well as superior sensor products to a demanding industry.
We are seeking a Lead Manufacturing Engineer is responsible for designing, implementing, and reviewing the procedures and equipment involved in the manufacturing process of assigned products.
Schedule: M-F, 7:30AM-4:00PM
Tasks/Responsibilities:
- Directly supervises and collaborates with the Process Engineer in defining the requirements and verification/validation of processes and/or equipment.
- Completes the design and fabrication of Production fixtures and jigs in SolidWorks during initial design, design improvements, or scaling up designs.
- Acts as a member of the Change Control Board to present, review, and/or approve manufacturing process changes and improvements of assigned products.
- Supervises the development of computer-aided design (CAD) and SolidWorks project drawings from staff engineers and related contractors.
- Ensures computer-aided design (CAD) files are maintained according to good documentation practices and established Quality Assurance procedures.
- In conjunction with in-house product experts, establishes and maintains necessary procedures to ensure that the device design - its components and configuration - is correctly translated into production specifications. Related tasks include:
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- Properly verifying and validating test plan, procedures, and test fixture documentation
- Completing process validation reports
- Performing and documenting a product-failure mode and effects analysis
- Confirming sufficient completion of final acceptance test reports
- Completing materials inspection plan, including necessity of first-article inspection and validation of in-process and final inspection plans
- Transfers the product design into production methods and procedures, in conjunction with Production, Engineering, Quality and related vendors/3rd Responsibilities include:
- Ensuring all part drawings and schematics are complete and ready for production
- Ensuring all standard component specifications are available for off-the-shelf parts
- Ensuring specifications and drawings are available for all custom parts
- Confirming that all parts have been assigned part numbers
- Confirming complete assembly procedures are finalized and readily available
- Determination of estimated time required to manufacture the device
- Determination of how many devices will be produced and according to what schedule
- Contributes to and supports a compliant Production environment including regulatory adherence, vendor qualification efforts, materials inspections, safety tests, ISO 13485 compliance, and CAPA system management.
- Constantly interacts with peers and senior leadership on the various individual projects associated with the above tasks.
Abilities:
- Able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist, and creative thinking is required.
- Able to lead and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
- Capable of operating independently with minimal technical direction
- Able to take direction and execute plans.
- Able to work in a changing environment and communicate changes.
- Superior organizational and communication skills
- Good written and verbal skills.
Preferred Experience/Minimum Qualifications:
Minimum Requirements of employee (education, previous use of specific equipment/technologies, prior experience etc.)
- Proven track record of successfully delivering new product/s through entire development cycle in a manufacturing environment.
- Knowledge of product development processes (PDP) - VOC to product launch
- Prior experience working within QMS design control processes.
- Practical knowledge of ISO 9001/13485
- Prior experience managing remediation and requirements of legacy products.
- Must be able to read, write, and speak in English.
- Minimum of 5 years' experience using SolidWorks, including 2 years of SolidWorks PDM.
- Prior experience with participating in Risk Assessments.
- Familiarity of PDM Vault preferred.
- Working knowledge of GMP requirements and best industry practices preferred.
- Previous management experience preferred.
Benefits- Competitive salaries
- Medical, dental, vision, and life insurance
- 401(k) plan
- Education assistance
- Corporate sponsored discounted gym membership
- 9+ paid holidays per year
- Vacation and sick pay
Applicants must be authorized to work in the U.S.