Angela Huenerfauth, Ph.D. Email & Phone Number

Basel, CH

San Jose, CA, US

• Managed timeline/financials and provided leadership for medical device projects worldwide
• Developed the customer product roadmap/vision, go-to-market strategies, and product positioning for a suite of pharmaceutical and medical device solutions.
• Launched key revenue-producing projects for the company
• Drove the company product strategy regarding custom and reusable product components as a cost-savings approach and to reduce time-to-market.
• Acted as customer consultative liaison for in-person joint steering committee discussions and workshops.
• Served as senior innovation leader for the customer project council regarding release strategy and architecture.

Franklin Lakes, New Jersey, US

• Managed and provided leadership for ten senior-level engineers and internationally located contractors for 20+ innovation projects worldwide ($300 million-dollar business).
• Developed innovation pipeline strategy and critical IP for digital health, vascular management, injection systems and anesthesia medical delivery solutions. Aligned approach with key stakeholders (marketing.
• Served as senior leadership core team member for innovation council (compliance to product development process, project milestone status) and developed budgets for all new innovation products.
• Strategized partnerships with academic institutions on advanced technologies for potential category innovations.
• Established / drove regular cadence of brainstorming sessions to promote R&D engagement in front-end innovation.
• Built a grassroots organization that specialized in rapid portfolio development with the following capabilities:o Clinical and market trend research to identify potential growth opportunities, strategic hunting.

Forchheim, DE

• Implemented a strategy for combining chemistry and immunoassay instruments into one next generation analyzer creating a potential $100 million-dollar revenue stream for the company (largest healthcare project in.
• Managed 6 full-time engineers, 3 contractors and several interns across three sites in NJ, DE and NY for multiple hardware and software projects. Developed the strategy for testing, practices and documentation.
• Created schedules, staffing resources and budgets for all the next generation analyzer projects in healthcare diagnostics.
• Performed impact and risk assessments for the next generation analyzer (identified initial/final severity and probability, mitigation, test method for verification of risk). Investigated feature functionality issues.

Forchheim, DE

See Description for "Senior R&D Engineering Manager"

Forchheim, DE

• Led cross-functional, global team (Engineering & Usability Element Team) for the duration of the next generation analyzer project. Developed schedule and staffing resources for the project including any gaps and needs.
• Performed usability testing for new product development of new immunochemistry instrumentation; usability tests include field research, surveys, concept walkthroughs, heuristic evaluations and alpha/beta testing..

Newark, Delaware, US

• Product and Process Engineer for Soft Tissue Patch (Transdermal Patch)
• Supported the development of the transdermal biomaterial patch per ISO 13485 (21CFR820 regulations) including design control and risk analysis.
• Created a revenue stream for the product team of $4 million dollars a year.
• Designed and conducted experiments and statistical analyses for verification and validation of new equipment (GMP) and software, including: FAT, SAT, IQ, OQ, POQ and PQ.
• Determined, via statistical analyses, process capability (Cp, CpK, CoV) and stability (SPC) for manufacturing process (which may include equipment and human error) to produce products that meet specifications. Product.
• Designed the assembly for two new catheter delivery systems, which allowed the company to enter a niche market and gain a revenue stream of $5 million a year.

Newark, Delaware, US

• Designed experiments to ensure that the composition of the foam product matched between an old and new production process. This design to cost reformulation allowed for a yearly savings of 45 million a year.
• Gathered and formalized product requirements. Coordinated a cross-functional team of engineering, manufacturing, and operations in the U.S. and Scotland. Led team meetings to establish consensus on requirements and.

Doctor Of Philosophy (Ph.D.), Technology / Information Management

Master Of Engineering (M.Eng.), Engineering - Project Management (Business)

Bachelor Of Engineering (B.Eng.), Mechanical Engineering (Biomedical Engineering)

Bachelor'S Degree, Biological Sciences