Allen An
Woburn,MA
Summary
Functional categories : Mechanical Engineer / Project Manager / Product Design Process / Production Engineer
Experience: Approximately 10 years of product development experience. Familiar with the medical device industry, regulations and requirements in the United States.
Marketing: Capable of assisting in market research. Previously responsible for product development and design at Medtronic.
Engineering: Proficient in CAD design software.
Leadership: Team lead, can handle work pressure, and has high execution capability.
Excellent communication: skills, strong writing and presentation abilities
Overview
11
11
years of professional experience
Work History
Senior Manufacturing Engineer II
Werfen
11.2023 - Current
- Lead manufacturing engineer for the localization project in China, your responsibilities include transferring knowledge of the current manufacturing line to contract manufacturers, which involves Bill of Materials (BOM), work instructions, Manufacturing Quality Plan (MQP), and equipment lists
- Guide contract manufacturers through IQ (Installation Qualification), PQ (Performance Qualification), and the establishment of new production lines
- Created work instructions and process flowcharts to oversee the project, lead the Research and Development Process Engineering team in parallel development of products and processes, and establish reliable manufacturing processes for equipment components, sub-assemblies, and final assembly
- Collaborate with design engineers and suppliers to optimize design for manufacturability.
Senior Process Development Engineer
Werfen
11.2021 - 11.2023
- Perform verification and qualification for new vendor's components.
- Lead DCRA meeting for new/change on critical components.
- Create working instructions, SOP, PM procedure ROTEM production line.
- Perform process FMEA exercise with cross function team.
- Leading on fixture design, testing, and the validation of the fixture.
- Create and execute IQ, OQ, PQ for process validations.
R&D Engineer II GYN
Medtronic
08.2016 - 10.2021
- Participate in market surveys (VOC) with the marketing department and customers, designing qualified solutions and concepts
- Collaborate with supplier teams to select suppliers for potential projects
- Using CAD software, they create models and drawings, conduct tolerance stack-up analyses
- Participate in FDA and BSI audits, implement changes required by the FDA, and ultimately obtain relevant certifications
- Laboratory supervisors, maintaining the alignment and procurement of experimental equipment.
R&D Engineer
Smith & Nephew
01.2014 - 08.2016
- Responsible for product design verification and validation
- Support On-Market sustaining activities
- Organize, plan, and participate in cadaver laboratory studies, accumulate anatomical research experience for instrument development
- Enter the operating room to access real cases, collect data for product development.
Education
MSc in Mechanical Engineering MBA -
Boston University
Boston, MA05.2026
Mechanical Engineering -
University of Massachusetts Lowell
Lowell, MA09.2021
Bachelor of Science - Mechanical Engineering Technology
Wentworth Institute of Technology
Boston, MA06.2013
Skills
- Project Management
- Technical Review
- Leadership/Customer relation
- CAD Solidworks/Creo
- Minitab
- Microsoft
- SAP
- Manufacturing CNC/Injection Molding
- Product Testing
Patents
- D790 697 Endoscope with Oblique Tip
- US Patent D791 Sheath & Endoscope with Oblique Tips
- US Patent D790 697 Endoscope with Oblique Tip
Projects
GEM5000 China Production Line Establishment- Determine project scope, participate in project planning, and establish a feasible timeline. Identify fixture and facility requirements. Draft Manufacturing Quality Plan (MQP) and work instructions. Complete drafts of IQ, OQ, PQ, MSA, testing plans, and reports.
Project Caravan- Generation of Truclear Tissue removal System, Lead test Engineer, in charge of test method validations, verification and Trace matrix. Performed test on prototype device, created design verification test protocols / reports. Established technical requirements with cross functional team and discuss new potential specifications. Completed first fully functional prototype device and present to management. Completed required documentations for quality and regulatory.
Project Fiesta- Hysteroscopic Fluid Management System, 2018 (Launched Product)- Subject matter expert on Fluid management system within the R&D team. Performed test on prototype device, created design verification test protocols / reports. Established technical requirements for Statement of Work. Completed required documentation for ATM (Approval to Market) process.
TRUCLEAR Ultra Mini Device, 2016 (Launched)- Lead test Engineer for design verification tests, and documentation activities. Designed a concept idea for new generation device. Created and verified prototypes and generate feasibility data. Established design inputs and created production specifications.
Oblique Tip Hysteroscopy, 2015 (Launched)- Created concepts prototype to reduce hysteroscope insertion force. Collaborated with manufacturer to drive reasonable tolerance and assembly requirements. Created new manufacturing method to resolve production issues and increase efficiency.
Languages
Chinese (Mandarin)
Native or Bilingual
English
Native or Bilingual
Timeline
Senior Manufacturing Engineer II
Werfen
11.2023 - Current
Senior Process Development Engineer
Werfen
11.2021 - 11.2023
R&D Engineer II GYN
Medtronic
08.2016 - 10.2021
R&D Engineer
Smith & Nephew
01.2014 - 08.2016
MSc in Mechanical Engineering MBA -
Boston University
Mechanical Engineering -
University of Massachusetts Lowell
Bachelor of Science - Mechanical Engineering Technology
Wentworth Institute of Technology