Sign in

Manager Product Development

Exeter, New Hampshire, 03833, United States
December 27, 2017

Contact this candidate

Robert M. Bilodeau

** ****** ***

Seabrook, NH **874


Professional Summary

Manager with 25 years of medical device experience in the areas of product development, production, and quality assurance, including design control compliance, internal auditing and regulatory affairs.


Da/Pro Rubber, Inc., a plastics injection molding company doing business in the medical, aerospace and industrial industries in Newburyport, MA March 2017 to October 2017

_ Quality Manager

Plan coordinate and direct members of the quality team to ensure continuous production of plastic injection molding operations.

Member of corporate quality team tasked with developing quality program to satisfy the requirements of ISO 9001:2015 and ISO 13485:2016.

Investigate and report on customer complaints, initiate CAPA’s and work with customers to find a solution to problems.

Management Representative for Newburyport facility. Was point for external audits.

Project lead to implement paperless system. Transferring all quality, production, training, etc. records to EPICOR/IQS.

Leader of lean implementation project.

MicroVision, Inc., a manufacturer of finished medical devices for the ophthalmic industry in Seabrook, NH July 2000 – Jan. 2017

-Quality Manager

Developed and implemented quality program to ISO 13485:2003

Generated and maintained all technical documents for CE marking of all manufactured products

Acted as company’s Management Representative

Responsible for two quality inspectors and two document control specialists

Lead for all ISO, FDA and customer audits

Conduct internal audits to ensure company practice is in accordance with internal procedures and external regulations

External audits of key vendors, ie. sterilization and testing facilities

Final approval of all technical documents

Lead in companies move to a larger facility included developing move plan, equipment validations, and ISO Class 7 cleanroom design.

-Production/Logistics Manager

Receive all customer orders, reviewing, purchasing, and scheduling

Plan daily production for 40 production workers

Plan and issue all manufacturing routings

Coordinate all ETO Sterile processing

Finished product release

Final approval on all shipping, international and domestic

-Engineering/R&D Manager

Project leader for all new product development

Work with customers to bring products from concept to production

Develop and implement manufacturing work instructions

Leader of lean manufacturing implementation team

Regulatory responsibilities

Churchill Medical Systems, manufacturer of finished disposable medical devices in Dover NH

May 1994- January 2000

- Director of Quality Affairs

Was jointly responsible with the director of manufacturing for the manufacturing facility. This consisted of everyday operations of 90+ employees manufacturing disposable medical devices in a Class 10,000 cleanroom

Trained and oversaw seven quality inspectors, two document control clerks, one engineer, one purchaser and a training coordinator

Project manager for ISO 9002 implementation and new product development

Developed, implemented, and maintained GMP, ISO and SOP manuals

Performed internal and vendor audits. Point for FDA and ISO Audits.

Wrote validation protocols and contracted ETO sterilization

Micromed, manufacturer of disposable medical devices in Portsmouth NH September 1991-May 1994

-Quality Assurance Manager

Responsible for all quality functions. Including implementation of quality system based on Mil.Std. 105E, engineering change order system, device master records, internal and vendor audits, ETO and Gamma sterilization

Performed internal, customer and vendor GMP audits. Point for FDA Audits.

Trained and supervised nine QC inspectors for incoming, in-process and final inspections

Introduced and aided in implementation of pull line manufacturing concepts

Member of ASQC since 1991

Lean Champion Development Training, August 2015

Visual Workplace, Visual Thinking Seminar, March 2016

Member of New England Lean Consortium since 2015

Served in US Navy 1979-1982

Attended Hesser College in Quality Assurance Management Program, earning 36 credits

Contact this candidate