Process Development Engineer

Employer
L&T Tech Services
Location
New Haven
Salary
Competitive
Posted
Mar 01, 2018
Closes
Mar 12, 2018
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Job Description

Welcome to L&T Technology Services - where we truly believe that our people are our biggest asset. We thrive on an innovative spirit, a quest for perfection, and the passion to outperform. This philopsophy has set the standard for our sustained success. Now, you, too can be part of our winning team when you join us in this exciting role!

Primary Responsibilities

  • Provide expert direction in setup, troubleshooting, repair, and continuous improvement of production equipment (automated suture manufacturing equipment)
  • Assure safety aspects of the equipment meet specified requirements to create a safe working environment for all employees
  • Act as subject matter expert on production equipment and processes
  • Provide training and development opportunities for associate engineers, manufacturing, and maintenance personnel
  • Provide training on automated manufacturing equipment
  • Assist with procurement, build, documentation, validation, and specification activities related to automated manufacturing equipment
  • Collaborate with procurement to review equipment design / build at suppliers and provide guidance on FAT tests
  • Provides documentation and education of equipment operation to engineering, manufacturing and maintenance personnel.
  • Maintains control of system software's, control logic program files, mechanical and electrical schematics, drawings and bills of materials and revision histories.
  • Assures back up of all electronic PLC and PC driven systems program media and revisions are up to date.
  • Reviews manufacturing equipment and process for improvement potentials using statistical data and analysis of OEE (Overall Equipment Efficiency) reports.
  • Reviews equipment improvement and replacement requirements and authors CER's (Capital Equipment Requisitions) for managers review and submission to obtain project funding, solidify project start and finish dates and document internal or outside contractor resources.
  • Teams with manufacturing and quality personnel on a daily basis to review, disposition production defects (QN's - quality notifications) and provide potential process or equipment corrective actions to assure production schedules are met.
  • Review product field returns with Quality Assurance personnel to determine root cause of potential manufacturing defects and provide process corrective actions if a defect trend analysis documents an unstable process.

Required Skills & Abilities

  • Bachelor's Degree in Mechanical, Electrical, or Industrial Engineering
  • 5 - 7 Years of relevant work experience - medical device domain experience required
  • Subject Matter Expertise in the field of Automated Manufacturing Equipment
  • Experience in equipment validation and FAT
  • Experience in process development, project management and installation qualification (IQ/OQ/PQ)
  • Knowledge of tool design and fixture design
  • Knowledge of electro-mechanical machine design
  • Foundational understanding of medical device regulatory standards: 21 CFR 820 & ISO13485
  • Ability to communicate effectively within multi-discipline environment at all levels of an organization

About L&T Technology Services

At L&T Technology Services, you will discover true freedom. As an employee, you will enjoy the power to create, feel the passion to deliver, and be empowered to demonstrate the panache of a leader.

We have an open culture where collaboration and creative ideas thrive. We are an equal opportunities employer and sucker for illustrious talent. We are traditional when it comes to believing in hard work, integrity, empathy and accountability. We are modern in building technology solutions to fuel the business transformation of our customers. And we are quite familial in our concern for the health and well-being of our most valuable asset - you. Regular medical check-up, yoga sessions, celebrations, sports and cultural activities form part of the work life at L&T Technology Services.

We have a competitive benefits package that includes attractive salaries, 401k with company match, and premium insurance benefits - medical, dental, and vision. We offer paid time off, flexibility, and ample opportunities to train and develop your skills.

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L&T Technology Services is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive due consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status or any other federally protected class.

Company Description At L&T Technology Services you will discover true freedom. As an employee you will enjoy the power to create, feel the passion to deliver and demonstrate the panache of a leader.

We have an open culture where collaboration and creative ideas thrive. We are an equal opportunities employer and sucker for illustrious talent. We are traditional when it comes to believing in hard work, integrity, empathy and accountability. We are modern in building technology solutions to fuel the business transformation of our customers. And we are quite familial in our concern for the health and well-being of our most valuable asset - you. Regular medical check-up, yoga sessions, celebrations, sports and cultural activities form part of the work life at L&T Technology Services.

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