Mark Schaefer Email & Phone Number

Durham, Nc, Us

As the Program Manager of Manufacturing Engineering I am responsible for product manufacturing and technology transfers programs across Bioventus manufacturing locations. Serve as the subject matter expert (SME) for Bioventus internal and external manufacturing capabilities. Participate in due diligence of acquisitions for manufacturing/ operations and help identify manufacturing and process improvements to drive manufacturing cost savings initiatives.Lead engineering activities for sustaining and Contract-Manufacturing Operations (CMO) by leading the transfer of products and technology into manufacturing with minimal direction from management. This includes existing technologies; manufacturing, process, and/or product manufacturing from Bioventus to supplier (outsourcing), from supplier to Bioventus (insourcing) or internally from one location to another (manufacturing network optimization)

Durham, Nc, Us

• Performed comprehensive due diligence of manufacturing capabilities and product cost structure during firm’s acquisition of Cartiheal Inc., a $315M company with revenue potential of $1.3B.• Performed value stream mapping (VSM) on SIGNAFUSE putty product family; and, identified and drove 18% cost-of-goods (COG) reduction, yielding $105K in annualized savings.• As engineering lead for design transfer to manufacturing, including process validations and scaling up to support 10%+ sales increase and 30% reduction in costs.• Determining viability of $2M+ equity investment in bio-technology firm’s ProCUFF, a bio-inductive collagen implant that regenerates rotator cuff tendon tissue, with Bioventus taking over what became a $5.5M+ project: Lead design and manufacturing engineer for its PEEK anchor and inserter, sourcing components and selecting and starting up new CMO to clean, assemble, and sterilize devices supporting pivotal animal study. • Lead engineer for transfer of collagen production to new CMO, including: timeline development, building custom equipment, tooling, startup, and first engineering production run within extremely aggressive four-month schedule; and enabling on-time 510(k) filing of ProCUFF. • Leading product development and design controls activities for new disposable Class II medical devices. • Writing and executing validations to support regulatory 510(k) filings.

Durham, Nc, Us

• As lead design and manufacturing engineer handling design history file and reformulation of collagen-based OsteoMatrix+ for commercial release, the firm’s first internally developed 510(k) product.• As lead project manager responsible for selecting new CMO for OsteoMatrix+, despite resistance, which was the driving factor in profitable launch generating first-year sales of $500K (2018), including: supplier visits, capabilities analysis, transfer planning, equipment sourcing, development runs, and production qualification.• Determined costing budgets totaling $2.3M to validate financial information for 510(k) development programs and COG models.• As primary manufacturing and design engineering resource on small high-performance team that developed and launched 510(k) product, SIGNAFUSE Strip, a synthetic bone-graft substitute for spinal fusion in July 2020, with annual sales of $880K. • As manufacturing Lead on SIGNAFUSE product line expansion, completing all design transfer activities necessary to support U.S. launch.• As internal lead auditor ensuring compliance to Medical Device Single Audit Program (MDSAP).

Youngsville, Nc, Us

• Led product development and design controls for new disposable Class II medical devices for niche firm. • Managed communications between customers, internal resources and external suppliers.• Created and maintained product drawings, product specifications, BOMs, and operation procedures.• Wrote and executed validations to support regulatory 510(k) filings.• Designed tools and fixtures as need to increase effectiveness of manufacturing customer products.• Provided technical guidance in medical product development.• Prepared proposals and quotes for new business opportunities, including program budgeting.• Tracked spending and provided reporting to management and customers.

Watford, Hertfordshire, Gb

• Supported multiple CMOs for $4.6B healthcare firm with 10.5K employees and a presence in 90+ countries.• Transferred and duplicated production lines, increasing capacity from 20K to 40K units per month. Ensuring redundant supply of high-volume medical devices that improve lives of patients worldwide.• Partnered with new product development team on RENASYS Soft Port.• Introduced new products at CMO’s in USA and low-cost countries. • Increased production of by 450% from expected 20K per year to 1M.• Drove $650K in annualized savings by applying continuous improvement methodologies and implementing cost reduction on wound-dressing manufacturing.• Designed processes for quality and efficiency and transferred medical device production to offshore CMOs; and provided technical support. • Justified quality improvements resulting in $866K annual savings.• Collaborated with cross-functional teams to implement new products at offshore CMOs. • Managed complex design changes requiring multiple validations across different supply facilities concurrently.• Built models that helped measure supplier production capacity. • Conducted process audits at CMOs as a subject matter expert (SME).• Created and implemented ultrasonic welding processes for near-hermetic seal applications. • Analyzed and used data to perform root cause analysis and corrective and preventive measure (CAPA) investigations for product complaints.• Generated and reviewed PFMEAs.

Watford, Hertfordshire, Gb

Justified and implemented capital projects in excess of 800KTransferred and duplicated production lines to ensure quality, efficiency and dual source strategies.Supported outsourced manufacturing partners (producing Class 2 medical devices) in engineering processes. Managed and oversaw process validations, product quality assurance and cost reduction programs.Trained outsourced partners on validations (IQ/OQ/PQ).Conducted Ultrasonic Welding training Classes.Analyzed Design of Experiments.

Watford, Hertfordshire, Gb

Implemented DAMIC improvement project resulting in manufacturing improvements of 600KCollaborated with team members in eliminating redundant processes to reduce manufacturing costs, utilizing skills including value stream mapping. Maintained responsibility for a million dollar equipment transfer from overseas – including equipment relocation, contractor supervision, equipment layout, installation processes and operational qualification.Efficiently developed, implemented and managed new production processes.Modified PLC source codes. Authored manufacturing process instructions and procedures.Lead Kaizen improvement teams.

Largo (Tampa Bay), Fl, Us

 Provided floor support for diverse FDA regulated manufacturing and assembly processes – including ultrasonic welding of plastics.  Collaborated with cross-functional teams in implementing new products into manufacturing.  Interacted with the Marketing department to ensure new products met customer requirements and expectations.  Coordinated and justified equipment rebuilds as required for business growth and quality/safety assurances. Lead Kaizen improvement teams. Devised and implemented various cost-effective and quality-driven process improvements.Developed, wrote and executed various verification and validation protocols. Created assembly procedures, work instructions.Designed, performed and analyzed Design of Experiments (DOE) to optimize process parameters. Analyzed and justified capital expenditure requests. Trained and supervised engineering interns.

Bridgewater, Nj, Us

Supported high volume FDA manufacturing production. Familiar with cGMP's, Implemented process improvements, Managed capital projects, Wrote validation protocols, Conducted validations and wrote reports, Drafted Standard operating procedures(SOP's), Organized machine rebuilds, Justified Capital expenditures in excess of 750K, Supported international B&L plants machine rebuild programs. January. 1998-December 2000.

Göteborg, Sweden, Se

Directed 9 hourly personnel, Maintained calibration system, Prioritized work flow through surface finish room, Prioritized repair of broken gauging and equipment, ordered replacement parts for gauging and equipment, Supported manufacturing operations, Programmed Zeiss CMM, Implemented new calibration system

Göteborg, Sweden, Se

Supported Daily Grinding Manufacturing Operations, Implemented process improvements, Managed Capital projects, Implemented new gauging techniques, Troubleshoot assembly issues for final product assembly, Reviewed Documentation, Developed Corrective actions for manufacturing problems, Developed Calibration procedures, Performed machine capability studies, Maintained Grinding Wheel Inventory

Bs, Manufacturing Engineering

Certification, Six Sigma Black Belt