About you: You will help make sure it all works together. You are a seasoned, proactive, and hands-on New Product Introduction Engineering professional with experience in charged particle systems, such as FIB, SEM, TEM, SIMS, XPS, etc. and ideally life science capital equipment. You enjoy owning the creation of robust and cost-effective new product introduction initiatives and processes. You thrive in a startup environment where you get to work with smart people from a wide variety of disciplines and are willing to help figure out the designs, tests and specifications related to new product introductions. You have leadership abilities, think independently and work without regular direct supervision.
- Prepare plans for all NPI projects and coordinate with all stakeholders and ensure good quality product documentation and identify all resources for manufacturing requirements and processes.
- Coordinate with Engineering team to develop strategies for new product releases and ensure that all manufacturing specifications are developed, and procedures are in place for all subsystems before any subcomponent is outsourced, manufactured and/or shipped to the field.
- Design, document, procure, qualify, implement, and improve fixtures, tools, test setups, and equipment.
- Provide engineering support for all activities in the product development processes.
- Monitor status of all new product developments to ensure execution of projects according to required policies, procedures and government regulations to meet manufacturing operations requirements.
- Coordinate with engineering, product management, supply chain, and manufacturing operations to develop and implement Manufacturing Plans for new products.
- Administer efficient f
- Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
- Monitor the design and development processes along with the manufacturing operations capabilities to evaluate and make design changes ensure product and process DFx (Manufacturing, Assembly,) input to enhance manufacturability and serviceability of new products.
- Work with design engineering and assist in transition of design prototypes into cost efficient and high-volume products.
- Provide technical support to the Materials Management team for all RFP and RFQ initiatives and administer effective use of manufacturing and outsourcing assemblies for products.
- Stay informed concerning new manufacturing and testing technologies.
- Ability to create work instructions, engineering change orders and meet regulatory compliances.
- Ability to work cross functionally at all levels from assemblers, engineers, scientists, to executives.
- Ability to lead and participate in Lean style project management methods.
- Ability to lead and develop manufacturing PFMEA’s.
- Ability to lead failure analysis and process improvements to increase quality and reduce field failures.
- Ability to support R&D with the first releases for V&V submission to regulatory agencies.
- Ability to create senior level reports for Senior Management and Executive level.
Minimum Qualification and experience:
- Minimum of 5-10 years’ experience with ion or electron optical systems, high voltage and vacuum systems is required.
- Proficiency with version control systems is a plus (e.g. Arena and NetSuite).
- Proficiency with basic data analysis (e.g. Excel) is a must. Experience with more advanced tools, such as Matlab, Python, or databases is desirable.
- Ability to create and adhere to project schedules.
- Strong verbal and written communication skills.
Education: BS in a relevant Engineering field. A degree in Physics or other scientific field with relevant professional experience is also acceptable. Masters or PhD is preferred.