Robert Walsh Email & Phone Number

Minneapolis, Mn, Us

Wayne, Pa, Us

Wayne, Pa, Us

Develop and implement manufacturing processes capable of producing products meeting design specifications and cost targets in a timely and efficient manner.Plan, coordinate, and execute process validation tasks and transfer validated processes and equipment into production for commercial manufacturing.Coordinate with production to produce initial finished goods inventory for new product launches.Principal Responsibilities• Develop and implement documented procedures to provide easy to follow instructions for production of products meeting design specifications and requirements.• Plan process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets.• Establish project timelines, track progress, manage to the schedule and communicate project status to management and the project leader.• Identify, specify and coordinate development, sourcing and qualification of: equipment, tooling, fixtures and component materials to produce product per design specifications.• Execute process characterization and investigations to establish process limits• Conduct test data analyses including: identification of outliers or non-normal data, generating data plots, general statistical analysis, and determining process capability.• Conduct Risk Analyses, Failure Analyses and Root Cause investigations and report results• Identify, propose, and pursue COGS reduction and/or quality improvement opportunities which align with company business objectives.• Coordinate, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds.

Eden Prairie, Minnesota, Us

Work within the U.S. based Research and Development function, to support, and execute internal and contract product development projects. This position is a key role within the R&D organization ensuring innovative and quality products are delivered on time while maintaining compliance with industry standards and regulations.Supported and executed 1 internal and 4 contract product development projects.Essential Functions:• Champion new product development projects: researching, developing and securing regulatory approval for new regenerative medicine products. • Create prototypes and conduct product testing.• Actively engage and collaborate on global cross-functional product development teams.• Assist with Design Control and Risk Management.• Prepare documentation following relevant internal SOPs. • Author engineering reports and presentations as required to document and communicate results. • Assist with preclinical needs assessments.• Assist for compliance with regulatory and industry standards (FDA, EU MDD, ISO, ASTM, etc.) as appropriate.• Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives.• Maintain laboratory notebooks.• Maintain a safe work environment. • Demonstrate expertise with tissue engineering, biomaterials, and polymers.• Adhere to safety precautions and protocols for safe handling and disposal of hazardous agents, reagents, chemicals, and materials.• Understand the medical device industry and other related disciplines preferred.• Have organizational skills with attention to detail.• Perform multiple tasks simultaneously and accurately.• Adjust rapidly to shifting priorities and variable workloads.• Have adequate computer skills for data acquisition, data management and visualization of experimental results.• Work under minimal supervision.• Effective problem solving and decision-making skills.• Knowledge of Outlook, MS Excel, MS Word, MS PowerPoint.

Chaska, Mn, Us

Work within the Aseptic Manufacturing department, to direct, and assist with formulation processing activities. This position is a key role within the department ensuring the manufacturing schedule is maintained and quality products and documentation are delivered while maintaining compliance with industry standards and regulations. Created and implemented a procedure that reduced the time and resources necessary to reprocess a nonconforming product.Essential Functions:• Responsible for directing all day to day processing activities for the aseptic formulation department.• Maintain the operational status of manufacturing equipment, clean rooms, utilities, and processes per the current standards of aseptic pharmaceutical science.• Effectively lead, train, and develop a team of 5 formulation technicians.• Ensure that aseptic products are manufactured per applicable regulations, Lifecore policies, and industry standards.• Review manufacturing processes and documentation for conformance to regulatory requirements, scientific principles, and efficient use of resources.• Assist the development department with the optimization of processes and development of new procedures while adhering to the criteria set forth by the quality management system.• In conjunction with the QC lab and validation department, prepare and perform cleaning validations on manufacturing equipment.• Investigate and approve variances, design control proposals, and change orders when appropriate.• Uphold proper GMP documentation.• Understand the key principles of formulation, sterile filtration, and aseptic processing methodologies.

Belgrade, Mt, Us

Perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. Support the activities of the Processing Team Lead(s) and Supervisors. Consistently yielded above-average quantities of allograft material during initial procurement.Essential Functions:• Produce bone and tendon grafts while adhering to standard operating procedures, aseptic technique, and current good tissue practices (cGTP).• Consistently yielded above-average quantities of allograft material.• Prepare chemicals and solutions used for processing.• Use surgical instruments to debride tissue and operate a variety of cutting, milling, and shaping tools.• Comply with FDA Code of Federal Regulations Title 21, Parts 820 and 1271; ISO, 13485; and American Association of Tissue Banks (AATB) standards.• Work closely with quality assurance and quality control to ensure the correct implementation of procedures and investigate product nonconformance.• Routinely conduct operational and performance qualifications for the research and development department to validate new equipment and/or return broken equipment to service.• Develop knowledge of the anatomy of human extremities.• Attain core understandings of biologics, medical device manufacturing, and cleanroom/aseptic environments.• Member of the Safety Task Force; responsible for identifying and resolving safety concerns at the workplace

Bozeman, Mt, Us

•Assist the Defensive Coordinator and Position Coaches in the management and administration of the football program and team.•Support scouting and recruiting activities.•Maintain and organize coaching material and practice schedules in the program office.•Foster relationships with players as a mentor on and off the field.•Lead review meetings giving constructive criticism and praise.•Comply with all NCAA and Big Sky Conference rules and regulations.

Bachelor Of Science (Bs), Biological Engineering

Education record