Rich Gallagher Email & Phone Number

Chapel Hill, Nc, Us

Raleigh, Nc, Us

My role is to manage, mentor, and strengthen the NPI team in order to launch and develop new products, establishing processes, and helping suppliers to be successful. To integrate products from pilot into production, creating reliable and validated products on schedule and within budget. Responsible for delivering strategies, defining project timelines controlling costs, mentoring team members and strengthening personnel via training and education, while establishing team culture. Manage design the transfer, establishing transfer metrics, and conduct manufacturing ramp-up plan, while establishing sustaining engineering goals and cost reduction targets. Develop risk management strategies and contingency plans related to manufacturing processes, new technologies or new materials, while building strong relationships with key suppliers.

Assure and validate packaging equipment and processes for new products, design and development of tooling and processes, while following the appropriate requirements for FDA 21 CFR 820 & ISO 13485 regulations. Deploy project management skills throughout the product development process, establish process development tools and goals for validating equipment involved in packaging of implantable medical devices.

Evaluate cardiovascular suture market for a VC private firm, generating market analysis report with options on manufacturability, costs, and market potential for Fluoropolymer PTFE Suture.Redesign “Biopsy Grasper” creating cost reductions and improve quality concerns in a platform product. Millions of unit’s sold/year, resulting in savings of ≈ $7.5 M/year, also elevating CAPA related issues associated to old design. Strategically layout a start-up NPD design group business model for a VC firm, with options to add prototype services including; design control, stage gate, CAD and software tools utilized in medical device industry.

Wayne, Pa, Us

Global leadership, creating and coaching highly effective and efficient teams. Proven track record in business development, design and manufacturing engineering of reusable and disposable products. Collaborate and identify strategic expectations and plans with in-house and external resources to foster partnerships and syncronize project requirements to meet the demands of marketing, quality and regulatory. Mentor and train engineering staff to support project pipeline, drive R&D productivity and consistency for both quality and on-time-delivery of new products increasing customer growth throughout multiple facilities.Identify resource needs and technology gaps to create and execute an R&D business plan, determine goals and objectives both domestic and internationally, establish multiple budgets and cost centers for a 3-5 year vision to support a $145M business unit. My leadership style is being direct and honest, but at the same time be respectful, embrace and achieve an environment for open communication, provide clear vision and identify achievable objectives for teams to be successful. By aligning both individual and project goals to create collaborative and cohesive teamwork in a fast pace environment.

Plymouth, Mn, Us

Championed multiple projects utilizing a combination of broad business acumen, technical depth, including organizational elements to execute projects for on time delivery and cost. Manage customer relationships, point of contact, and product development pipeline activities. Cross-functional teamwork and leadership building camaraderie and adopting a "whatever it takes" approach to get the job done right.. Created, hired, and trained program managers resulting in schedules and costs to within 10% of forecast. Key contributor in change management, establishing accountability, project review dashboards for senior management, project ownership and educating the organization in program/project management practices.

Pioneered program management leadership role establishing accountability and focal point of contact. Proven ability to scope, document, resource load projects including manage design, development, manufacturing and production engineering in a hands-on diversified leadership role. Negotiate with other department leaders to develop and manufacture safe and effective products in compliance with QSR, cGMP and ISO requirements resulting in 3rd party audit free findings.

Victor, Ny, Us

Transform a “think-tank” operation into a full-scale product development business, serving as technical architect for engineering and metrology. This included creating incoming inspection practices, develop the companies cGMP practices, policies, and procedures as well as write, train, and initiate design control procedures.

Managed staff of 30+ toolmakers, mechanics, and engineers i.e. (manufacturing, material and design engineers). Responsible for new products pilot manufacturing pipeline support; designing, fabricating or acquiring dies, molds, tooling, test equipment or assembly technology for a broad breathe of product portfolios. Coordinate and negotiate with suppliers to provide cost efficient, ergonomically safe tooling while adhering to project schedules and maintain a “10K clean room” environment. •Accelerated product development by utilizing expert consultants on technical, systems-related, and process related topics for approximately 25 new programs reducing development cycle.•Negotiated contracts with outside services (i.e. constructing labs, machine shops, rigging equipment).•Ascertained DFM/DFA techniques to save $100k”s utilizing World-Class Manufacturing practices.•Constructed assembly lines from prototype to production through to maturity, including transfers.

Amsterdam, Noord-Holland, Nl

Pioneered a team of five project engineers, utilizing DFMEA to streamline components, assembly time reduction and vendor relationships. Prioritized 20 unique programs orchestrating Early and Continuous Supplier Involvement practices, served as a “fire-wall” between design and manufacturing engineers. •Develop, designed and launch capital equipment projects, hardware and software products, as well as disposable products, combining components or features to reduce cost and cycle times per unit.

Project Manager: Created capital & expense budgets totaling $6M for complete product line portfolio. Led project team from concept to commercialization for disposable devices, working with all departments to properly document design control, establish schedules, build prototypes, manufacture and test product for compliance, packaging, and literature.Sr. Mfg. / Dev. Eng: Mentor and train engineers in product development techniques, in-vitro and in-vivo testing to validate products per design specifications. Assist marketing and surgeons on focus studies and clinical trials to ensured design efficacy.Mfg. / Dev. Eng: Trouble shooting components, vendor tooling, inspection methods, assembly lines and related issues using DOE methodologies. Develop product concepts, prototypes and test methods for new Class I, II, III medical devices.

Ms, Management Engineering-(Mba Equivalent)-Focused On Medical Device Industry

Bs, Industrial Technology Manufacturing

As, Manufacturing Engineering

High School, Machine Tool Department