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.• Constructed portfolio-expansion business case for products launching globally (market size / segmentation, regulatory / legal pathways, manufacturing / operations strategy). • Defined/formalized voice of customer product requirements, use cases, user needs and product specifications per ISO 13485 (21CFR820: design inputs, outputs, review, verification, validation, transfer, changes, and history file).• Directed teams to manage design/change control, risk management, regulatory, OSHA and usability engineering (i.e. EU medical device directives, FDA regulations, IEC62366, ISO 13485, ISO 14971).• Acted as ScrumMaster and Product Owner for cross-functional teams (Jira/JAMA) for Agile software development (managed backlog, prioritized key epics/features within sprints/releases, road mapping, burndown charting, defect management, sprint ceremonies) with the customer as part of the process.

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, regulatory, medical affairs, operations, manufacturing, quality, finance) and drove implementation to bring products to market/product line launch.• 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 grounds, and unmet customer needs for transformative products. o Innovation concept development with a commercial, technical, and clinical viewpoint and roadmap advancement of products through the innovation phase gates.o Ethnographic, bio-design market research studies, competitive analysis, techno sensing, prototype creation, IP assessment, cost-reduction / early product launch challenger sessions, and evaluation of possible partnership / acquisition scenarios.

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 Siemens’ history).• 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 throughout project milestones, and successfully led projects through the Product Development Process (PDP) for feasibility, verification and validation. Held end-of-year reviews for team, and created goals and development plans for each individual. • 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 throughout product lifecycle.

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 for the project. • 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. Applied usability principles and research techniques to the design and evaluation of safer and more reliable products.

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 and Process Engineer for Two New Catheter Delivery Systems. • 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. • As per ISO 13485, performed and documented feasibility studies on early prototypes, POQs on verification settings and PQs on the variation of those settings for multiple processes for the New Catheter Delivery Systems product lines.• Partnered with Quality Engineering and Manufacturing to manage customer complaints, CAPAs and internal non-conformances. Performed root cause analysis (included designing experiments) and implemented corrective actions.

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 present results

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