Process Development Engineer

Background and experience: BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Knowledge of and experience in pilot/production line set up and validation in Controlled Environment. Experience working under quality systems designed to meet governmental regulations such as

FDA QSR, ISO

13485, the MDD, and knowledge of relevant standards. Ability to detail project plans effectively. Familiar with

GMP, GDP

procedures and requirements. Familiar with Design Control procedures and requirements. Excellent communications skills (both written and verbal) required. Ability to work independently or in team setting required. Project management experience preferred. Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations. Experience working with ERP/MRP/Documentation control systems Understanding of contracts (supply, services, non-disclosures agreements, etc.).Skilled in the use of Microsoft office suite, especially Word, PowerPoint, Excel Previous exp. in medical device company with experience and emphasis on single use devices and consumables highly preferred Excellent communications skills (both written and verbal) required Ability to work independently and to prioritize activities and workload As a technical individual contributor or team leader, oversee the builds for single use device and consumable products Manage in-house and contract manufacturing activities and relationships to ensure single use device and consumable products are manufactured in accordance with product plans and quality/regulatory requirements. Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects. Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields. Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability. Participate the selection of suppliers for manufacturing components. Work closely with Quality to create manufacturing and process related SOPs and Wis. Develop manufacturing processes and Manufacturing Process Instructions (MPI's) and lot history records (LHR's) or Device History record (DHR's) in collaboration with R&D and Quality. Perform time studies for each manufacturing process and identify process development initiatives. Ensure that all single use device and consumable products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements. Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects. Provide oversight and coordinate cross-functional operations project team activities from early project conceptualization through clinical testing. Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met. Participate in manufacturing team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff. Develop manufacturing specifications for single use device and consumable products; coordinate all process validation activities with Quality- IQ/OQ/PQ. Determine tooling, equipment, and fixture needs for the timely and cost-effective manufacture of single use device and consumable products. Define requirements to ensure smooth transition of single use device and consumable products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements. Work with suppliers to ensure parts/services are properly documented and meet specifications. Manage specifications for sub and final assemblies; identify tooling requirements - design/document/procure/verify tooling. Establish manufacturing line and approve DCO's for manufacturing engineering. Define critical process outputs and ensure that MPIs and training methods confirm the outputs. Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability. Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost-effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company's Quality System requirements. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and applicable regulatory regulations. Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality. Manage individual projects and deliver status reports as required. Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans. Ensure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements. Actively promote and support the company's Management Review process. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

INDTS Pay:

$70.00 - $80.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Work Location:

In person