Quality Engineer Job Opening

FlexDex Surgical, a medical device startup based in the Ann Arbor (MI) area, is working to transform minimally invasive surgery world-wide. FlexDex’s line of surgical instruments are based on an elegant mechanical design that offers finesse, dexterity, and instinctive control so far seen only in multi-million dollar robotic solutions. The company’s mission is to globally democratize minimally invasive surgical procedures that are currently too complicated or too expensive.

Several video demonstrations are posted on the company’s website: www.flexdex.com/videos.

To realize its vision, FlexDex is looking for a Quality Engineer to join the team!

Quality Engineer uses Quality Engineering principles, tools, and techniques to develop, optimize, and support systems and processes that are aligned with the overall strategy of FlexDex Inc. The FlexDex Quality Engineer II is responsible for design controls and process controls related to FlexDex development and sustaining engineering.

Furthermore, this role is also responsible for the Product Surveillance process including investigation, follow-up, and reporting.

This position reports to the Manager of Quality and Regulatory.

Main Responsibilities:

  • Support, consult, train, and lead quality improvement projects throughout the life-cycle of FlexDex products, including product design, development, product surveillance, and process improvements.
  • Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, manage risk through risk analysis tools, design and process verification and validation, conduct process audits and assist in system audits.
  • Provide statistical support and use statistical means for development, validation, and improvement, as needed. This includes possible use of DOE, Pareto, ANOVA, SPC, capability analysis, etc. Summarizes, analyses, and draws conclusions based on the objective evidence.
  • Investigate nonconforming material and assist with the determination of root-cause
  • Investigate, implement, and verify Corrective or Preventive Actions as dictated by Quality Management.
  • Manage the Product Surveillance program. Responsible for timely investigation and reporting. Works with other functions to identify root-cause, adequate containment, and appropriate correction, where appropriate.

Educational Requirements:

A bachelor’s degree (B.S.) in engineering, science, mathematics, or statistics is preferred. Equivalent combination of education and experience is acceptable.

Additional Skill Requirements:

  • Two years of related experience is preferred
  • Experience in medical device or other regulated industry is a plus
  • The ability to prioritize and manage multiple projects with no negative impacts to business
  • Strong communication skills, both verbal and written
  • The ability to work with, and lead, a wide variety of people effectively and efficiently.

Training Requirements:

  • ASQ Certifications such as CQE, CQA, SSGB, SSBB, are desired
  • Quality systems and process audit certification and/or training is desired

If you fit well to the Quality Engineer opening, send your resume, cover letter and any work example/references to Jeff Flint. at jeff.flint@flexdexsurgical.com with the subject "QUALITY ENGINEER JOB OPENING"

 

FlexDex is Hiring Bright(on) Mechanical Engineers!

R&D (Mechanical Design) Engineer Position Openings

FlexDex Surgical, a medical device startup based in the Ann Arbor (MI) area, is working to transform minimally invasive surgery world-wide. FlexDex’s line of surgical instruments are based on an elegant mechanical design that offers finesse, dexterity, and instinctive control so far seen only in multi-million dollar robotic solutions. The company’s mission is to globally democratize minimally invasive surgical procedures that are currently too complicated or too expensive.

Several video demonstrations are posted on the company’s website: www.flexdex.com/videos.

To help realize its vision, FlexDex Surgical is looking for highly creative and self-motivated engineers who are passionate about positively impacting healthcare access. A Bachelor’s degree in engineering and strong experience in mechanical design, development, and fabrication are required. Key skills and attributes needed for the job include:

  • Self-motivation, passion for technology innovation, and strong desire to make an impact

  • Strong mechanical engineering and design experience in linkages, transmissions, cable drives, cams, pulleys, shafts, fasteners, structures, etc.

  • Working knowledge and experience in Design for Manufacturability/ Assembly/ Part-count Reduction, and Material Selection.

  • Experience in prototype design, fabrication, assembly, and debugging. Experience with traditional fabrication processes as well as rapid prototyping methods is desired.

  • Proficiency in 3D CAD, engineering drawings, GD&T, and tolerance stack-up analysis.
  • Experience in medical product design, development, and manufacturing will be a plus.
  • Strong teamwork, project management, and communication skills.

FlexDex Surgical offers a fast-paced and rewarding environment for employees to contribute to the company’s mission, grow professionally, and have fun. Please contact jobs@flexdex.com with a detailed resume and a research/design/development portfolio. The company offers a competitive salary, benefits, and stock options. Here are some great reasons to live and work in the Ann Arbor, MI area: http://www.annarborusa.org/live-here/facts-rankings.

FlexDex Surgical Completes $5.0 Million Financing and Prepares for Commercial Launch

Brighton, Michigan – July 12, 2016 – FlexDex Surgical announced that it has completed a $5.0 million Series B financing.  Financing was led by current investors and included the co-founders, board members, individual investors and distributors. Proceeds from the financing will be used to commercialize the Company’s first product, the FlexDex Needle Driver and fund development of a second generation device and a catalogue of instruments for laparoscopic surgery.
“We are very pleased to have so many successful business leaders and healthcare professionals participate in our financing. This financing will support our goal to provide enhanced dexterity instruments to every surgeon, in every operating room all over the world at an affordable cost” said Tom Davison, Chairman and Chief Executive Officer of FlexDex Surgical.


About Laparoscopic Surgery
Laparoscopic Surgery is the minimally invasive approach to abdominal surgery during which the abdomen is inflated with gas to create an operating space.  Small incisions are made to accommodate an endoscope for visualization and long narrow surgical instruments.  Laparoscopic surgeons require specialized training and years of experience to become proficient.  Recently, robots have been introduced to facilitate advanced laparoscopic procedures with improved dexterity compared to traditional laparoscopic instruments.  Surgical robots are very expensive ($millions) and require special training for surgeons and the operating room staff.


About FlexDex Surgical
FlexDex Surgical www.flexdexsurgical.comis developing the FlexDex platform to provide surgeons with high performance and cost effective minimally invasive surgical instruments.   The company’s focus is to enable advanced minimally invasive procedures with greater precision and less fatigue.  FlexDex was developed at the University of Michigan by co-founders Shorya Awtar, Sc.D., James Geiger, MD and Greg Bowles.  This platform technology enables highly intuitive, one-to-one mapping of the surgeons arm and hand motions to the articulating instrument inside the patient’s body.  The patented “Virtual Center™” of the FlexDex platform is a simple mechanical design that, we believe, will greatly enhance the capabilities of all Minimally Invasive Surgical (MIS) instruments and endoscopes.
Legal Disclaimer:  These statements have not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

FlexDex Gen 1 Needle Driver Render

Best Regards,
Thomas W. Davison, Ph.D.
Chairman & CEO
774-571-9558
Tom.Davison@flexdexsurgical.com

FlexDex Surgical Names Randall Sullivan President and COO

Brighton, Michigan, April 18, 2016 – FlexDex Surgical announced today that it has named Randall Sullivan President and Chief Operating Officer. Mr. Sullivan most recently was Sr. VP of Operations at Silkroad Medical, Inc.


FlexDex recently completed the development of its first product, the FlexDex Needle Driver.  FlexDex instruments utilize the company’s patented “Virtual Center™” technology to provide surgeons with robotic-like dexterity for the price of low cost mechanical instruments.
Mr. Sullivan worked with FlexDex as an advisor during its fast paced product development program.  He will now lead FlexDex’s growth as the Company commercializes its first product and develops an extensive line of products based on the FlexDex technology platform. “Randy’s decades of experience in the medical device industry with direct expertise in engineering, manufacturing, facilities, quality assurance and customer service, will be invaluable in leading FlexDex Surgical through this new and exciting period of growth”, said Tom Davison, Chairman and CEO who added “FlexDex is poised to grow for many years as a result of our extensive product pipeline opportunity for the FlexDex platform.  Randy has a very successful track record in leading eight medical device companies through continued growth and highly successful outcomes that will contribute directly to FlexDex Surgical’s future”.


“I am very pleased to be joining the outstanding team at FlexDex. I am looking forward to helping continue the development and commercialization of this game changing technology that has the potential to bring robotic like dexterity to surgeons in every operating room throughout the world at a fraction of the cost of surgical robots”, said Mr. Sullivan.

 

FlexDex Surgical Announces Clinical Advisory Board Appointments

Brighton, Michigan, June 15, 2015 – FlexDex Surgical announced today appointments to its Clinical Advisory Board (CAB).  FlexDex is developing a suite of laparoscopic & minimally invasive instruments.   These instruments utilize the company’s patented “Virtual Center” technology to provide surgeons with robotic-like dexterity for the price of low cost mechanical instruments.

FlexDex co-founder and Chief Medical Officer, James Geiger, MD leads the clinical advisory board. Dr. Geiger is a Professor of Surgery in Pediatrics and the Executive Director of the Medical Innovation Center at the University of Michigan.  Dr. Geiger invited Daniel Herron, MD, Jeffrey Ponsky, MD, Steven Rothenberg, MD and Nathaniel Soper, MD to join the CAB and he commented; “FlexDex is honored to have this group of internationally recognized leaders and innovators in laparoscopic surgery involved with our company”.

Dr. Herron is the Chief of Laparoscopic and Bariatric Surgery, Icahn School of Medicine at Mount Sinai in New York City.  Dr. Herron is on the editorial boards of two major obesity journals and 4 laparoscopic surgery journals.

Dr. Ponsky is a Professor of Surgery at the Cleveland Clinic, Lerner College of Medicine.  He was Director of Endoscopic Surgery and was the first Executive Director of the Minimally Invasive Surgery Center at the Cleveland Clinic. Dr. Ponsky is a past president of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) and the American College of Surgeons – Ohio Chapter.

Dr. Rothenberg is in private practice with Rocky Mountain Pediatric Surgery in Denver.  Dr. Rothenberg is the past president and founding member of the International Pediatric Endosurgical Group (IPEG).  Dr. Rothenberh was the first Chair of the Pediatric Committee for SAGES and was a member of the Board for 6 years.

Dr. Soper is Professor and Chair and Chief of Surgery at Northwestern University.  Dr. Soper is a past President of SAGES and the International Society of Digestive Surgery (ISDS).  Dr. Soper is on the editorial board of Annals of Surgery, Surgical Endoscopy, Journal of the American College of Surgeons, Journal of Gastrointestinal Surgery, and World Journal of Surgery.

Thomas W. Davison, Ph.D.

Chairman & CEO

774-571-9558

Tom.davison@flexdexsurgical.com