Medical Device Senior Manufacturing Engineer

Medical Device Senior ManufacturingEngineer

Cambridge MA

Must bea US Citizen or Green Card Holder.

This is a 5Month Contract NO C2C.

The Sr.Manufacturing Engineer will have high collaboration betweenR&D Pilot and commercial manufacturing and contribute fromEarly Human Use to the commercialization of new products.

The Sr.Manufacturing Engineer will also ensure that design andmanufacturing processes are characterized robust scalable utilizebest technologies reflect standard work are capable and compliantwith Regulatory requirements and are validated for Design ControlManufacturing using LEAN Six Sigma Design for Manufacturing andDesign for Cost Methodologies.

The Sr. Advanced ManufacturingEngineer will act as a liaison between R&D SupplierDevelopment Quality and Operations team members assigned to theproject.

Key Responsibilities(Do) :

Developed and optimizedefficient costeffective and validated manufacturing processes formedical devices focusing on capital and / or disposable devicesincluding assembly lot release testing sterilization andpackaging.

Produce productionlevel assembly andpart drawings for all components and subassemblies.

Incorporate Design for Manufacturing (DFM) Six Sigma andLEAN principles into product and process designs to ensuremanufacturability minimize costs and achieve optimal productionefficiency through activities like DFMA reviews and cycle timeoptimization.

Proactively identify and evaluatepotential contract manufacturing partners by analyzing quality costdelivery timelines and regulatory compliance capabilities torecommend optimal providers.

Lead andcollaborate with contract manufacturers in selecting and developingthe most efficient and reliable manufacturing processes and siteswhile fostering strong partnerships.

Act as theliaison between Contract Manufacturing Organization (CMO) and Canonto coordinate manufacturing activities as directed byManagement.

Review engineering productspecifications and CAD data / drawings as part of the design reviewprocess to ensure they meet industry and manufacturing standardsand practices.

Responsible for part / drawingrelease and the accuracy of the Bill of Materials (BOM).

Drive the development and execution of complexexperiments and tests (including writing and executing protocols)on new or existing product lines to qualify and validatemanufacturing processes analyze results make recommendations anddevelop reports.

Responsible forCharacterization and Validation activities including CTQ flowdownand identification of critical control points withinmanufacturing.

Deploy manufacturing riskassessment and mitigations including handson and resourceful actionplans.

Developing and maintaining manufacturingwork instructions equipment instructions and other documents thatrequire quality management system controls.

Coordinating technical communications between Canon and contractmanufacturers including design transfer.

Providing technical expertise in conducting pFMEA and developingprocess validations.

Sharing expertise in LeanSix Sigma process excellence principles.

Collaborating with crossfunctional product development teamsincluding project managers optical engineers mechanical engineerselectrical engineers software engineers quality engineersregulatory specialists clinical specialists marketers buyers andothers.

Results Expected (Deliver) :

Development and maintenance of project task list for DFMActivities

Create and maintain uptodate BOMswork instructions and travelers.

Creation andmaintenance of pFMEA

Required Knowledge Skillsand Abilities : (Hiring Companies ATSQuestions) :

1. Doyou have a bachelors degree or higher in Mechanicalengineering.

2. Do you have 5 years ofexperience in medical device manufacturing engineering including atleast three years in new product development design transfer toproduction and validating processes.

3. Do youhave Excellent modeling and drawing skills using SolidWorks including proficiency withassemblies that contain dozens of parts.

4 Doyou have Experience working with contract manufacturers / vendors forcapital equipment electronics testing and / or catheter manufacturingis strongly preferred.

5. Do you have Proventrack record in design transfer process validation and knowledge ofsterilizable polymers and catheter fabricationtechniques.

6. Do you have Technical expertisein DFM Six Sigma LEAN cGMP and processvalidation.

7. Do you have Proficient inSolidWorks with experience in tool and fixture design.

8. Do you have Highly proficient in Microsoft Office Suiteand statistical analysis software like Minitab orJMP for process monitoring and improvement

9. Do you have Lean and / or Six Sigma certifications. Niceto have :

10. Must be a US Citizen orGreen Card holder.

Remote Work :