Douglas Cuny, Ms Email & Phone Number

Shelton, Connecticut, Us

• Directed technical sustaining activities for 2600 products ranging from single use disposables to capital equipment in a $1.2B business.• Assessed capabilities and capacity, restructured the team to streamline responsibilities, reduce redundancies, and improve efficiency. • Grew team from 24 people to 45 people in 5 international locations, adding subject matter experts in key areas to address gaps. • Developed service branches within the team to handle specialized work streams in biocompatibility, packaging and design.• Led MDR remediation efforts around 81 technical files in three main areas: 43 device files, 10 equipment files and 28 IVF media files.• Drove complaint investigation and resolution on key products.• Active management of R&D CAPAs from root cause to effectiveness checks.

Shelton, Connecticut, Us

• Responsible for leading R&D, Manufacturing, Product Quality, Supply Chain and Facilities activities.• Guided corrective actions and supply chain recovery in response to audits.• Drove R&D activities leading to the launch of two new derivative products.• Reduced COGS by 30% and product lead time by 60%.• Formulated and executed a plan for supplier exits in conjunction with on boarding of new suppliers.• Screened, selected and negotiated favorable lease terms on a new Class A office space.

Shelton, Connecticut, Us

• Responsibility for leading Manufacturing, Supply Chain and Facilities functions for an early stage company.• Prioritize and coordinate internal and external resources across Operations, R&D, Marketing, Quality and Regulatory functions in support of Company sales objectives.• Direct capacity planning, vendor strategy and selection, assembly operations in multiple facilities, cost reduction, component fabrication and capital tooling purchases. Products supported include sterile packaged single use disposables, non-sterile implants as well as reusable instrument sets and represent $15M in spend.• Coordinate product supply to support sales of an 8400 SKU business, ranging from 45% growth on new introductions to 10% growth on core products. Direct company buying, contract development, price negotiations and supplier business reviews. • Manage maintenance, expansion and build projects for a 39,000ft2 facility, including Class A corporate office space, warehousing, distribution, R&D lab space and a surgical training suite.

Shelton, Connecticut, Us

Shelton, Connecticut, Us

• Assumed leadership of a project as early testing pointed to a potential performance issue. Investigated the situation with surgeons and correlated their experiences to initial project assumptions. Determined the project assumptions needed to be adjusted. Formulated and built a revised test model, and guided the redevelopment of the product. Successful field test and launch of the product followed 14 months later. • Guided the redesign of a reusable device into disposable device and coordinated the selection of appropriate manufacturing processes and vendors. Standard cost went from $2700 to $35 with $150k in capital investment. • Oversaw a component tooling upgrade program to address the need for higher volume production. Identified potential suppliers, initiated site visits and ultimately selected production vendors.• Guided the development and launch of 5 derivative projects based on previously developed product architecture.• Designed, built and outfitted the Fusion R&D departments’ first dedicated lab space. Two years later redesigned and upgraded lab space as a result of corporate expansion.• Initiated first company efforts aimed at providing emergency help to employees. Lobbied for and purchased an Automated External Defibrillator (AED) and coordinated training for emergency responders.

Shelton, Connecticut, Us

• Led the development of the first project platform under new corporate guidance. Successfully delivered the $5.3M project on time. Ran simultaneous production in two facilities to meet launch requirements. Transfer to production was the fastest in company history for a stapling product.• Assumed leadership of a team working on the next generation of the company’s largest revenue contributor. Revised the scope of the project and created a market segmentation plan that was accepted at all levels of the company. Refocused team to meet new objectives, coordinated the roll out of the new direction across all functional areas.• Took over the development efforts for a $7M product platform that was judged as unsuitable by target consumers. Revised the scope of the 3-year-old program, and four months later produced well received functional models at a lower cost. Revised product outperforms predicate devices in all key performance indicators at a lower standard cost.• Formulated and executed plan to achieve cost savings in the purchase of a component from an outside supplier that produced annual cost reductions of $1.6M. Initiated investigation with supplier to identify and evaluate component’s cost drivers. Developed action plan, secured budgetary support and monitored production at sub-contractor facilities.• Heavily involved in and frequently requested to perform site visits to support key strategic initiatives related to securing contracts. Active participation with surgeons and materials managers to develop and expand relationships resulting in product evaluations and collaborative research projects. • Initiated and planned redesign of office space yielding improved workspaces and a 50% increase in capacity. Coordinated moves of 65 employees through construction period with no down time. Planned and executed secondary effort to convert under utilized space into 18 additional workspaces.

Bachelor Of Science - Bs, Mechanical And Aerospace Engineering

Master Of Science - Ms, Management Engineering

Education record