Senior Validation Engineer

7 days ago

Warminster, United States LifeLens Technologies Inc. Full time
Job DescriptionJob DescriptionSalary: Commensurate with Experience

LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.


You will collaborate with Process and Quality Engineers to draft and execute process validation protocols (IQ, OQ, PQ) and document their results.  Your efforts will demonstrate processes are running according to specifications, within applicable regulations and to ensure data integrity and the production of quality products.

 

This is a full-time, on-site position.


Responsibilities:

  • Participates in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.
  • Executes equipment and process validation studies (IQ, OQ,PQ) to include protocol preparation, scheduling, execution, including data analysis and generation of summary reports.
  • Execute gage R&R and test method of QC test and inspection methods.
  • Ensure integration of validation schedule in the production schedule for implementation of validation activities and ensure due dates and customer needs are met.
  • Ensure compliance with LifeLens’ SOPs and Quality Standards for validation and qualification activities.
  • Assess the potential impact of changes to qualified systems; Identify and implement validation best practices to continuously improve the site validation program.
  • Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
  • Support regulatory audits through the preparation, defense, and interaction with auditors in areas related to sterilization, commodity prep, and formulation equipment.
  • May mentor junior-level engineers.
  • Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects in collaboration with a team.


Qualifications:

  • Bachelor’s Degree in a related discipline (e.g. Engineering, Physical or Life Science) with an advanced degree preferred.
  • Minimum 7 years experience in medical device quality or process engineering that includes direct experience planning, writing, and executing process validations
  • Demonstrated success in executing process validations in a medical device manufacturing environment.
  • Knowledge of FDA medical device regulations and international standards for medical devices.
  • Certified Quality Engineer (CQE) certification is a plus.


Benefits:

  • Health Insurance
  • Dental & Vision Insurance
  • Stock Options
  • Paid Time Off
  • Flextime

 

  • Senior Validation Engineer

    6 days ago

    Warminster, United States CareerBuilder Full time

    Sr. Validation Engineer Ivyland, PA (NO C2C) My client is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. You will collaborate with Process and Quality Engineers to draft and execute process validation protocols (IQ, OQ, PQ) and document their...

  • Senior Product Development Engineer

    1 week ago

    Warminster, United States CareerBuilder Full time

    Job Description Job Description Salary: Commensurate with experience LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. We are seeking to hire a Senior Product Development Engineer. This is a full-time, on-site position. The ideal...

  • Senior Product Development Engineer

    3 days ago

    Warminster, United States LifeLens Technologies, LLC. Full time

    Job Description Job Description Salary: Commensurate with experience LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. We are seeking to hire a Senior Product Development Engineer. This is a full-time, on-site position. The ideal...

  • Senior Product Development Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.We are seeking to hire a Senior Product Development Engineer. This is a full-time, on-site position. The ideal...

  • Senior Product Development Engineer

    7 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.We are seeking to hire a Senior Product Development Engineer. This is a full-time, on-site position. The ideal...

  • Senior Systems Engineer

    Found in: Appcast Linkedin GBL C2 - 6 hours ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • Senior Systems Engineer

    1 hour ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • Senior Design Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. The Senior Design Engineer directly supports R&D Engineering and Manufacturing Development with the...

  • Senior Design Engineer

    7 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. The Senior Design Engineer directly supports R&D Engineering and Manufacturing Development with the...

  • Senior Design Quality Engineer

    7 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. We are seeking to hire a Senior Design Quality Engineer. In this role, you will support the design...

  • Senior Design Quality Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. We are seeking to hire a Senior Design Quality Engineer. In this role, you will support the design...

  • Senior Network Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experience LifeLens Technologies, Inc. is a pioneering technology company specializing in the development of state-of-the-art IoT devices tailored for the medical and government sectors. We are dedicated to delivering seamlessly integrated solutions, combining on-premises infrastructure with Azure Cloud...

  • Senior Network Engineer

    2 weeks ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experience LifeLens Technologies, Inc. is a pioneering technology company specializing in the development of state-of-the-art IoT devices tailored for the medical and government sectors. We are dedicated to delivering seamlessly integrated solutions, combining on-premises infrastructure with Azure Cloud...

  • Senior Mechanical Engineer

    3 days ago

    Warminster, United States LifeLens Technologies, LLC. Full time

    Job Description Job Description Salary: Commensurate with Experience LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. The ideal candidate is a self-starter who enjoys working within teams and independently. You are...

  • Senior Mechanical Engineer

    7 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with ExperienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring.​The ideal candidate is a self-starter who enjoys working within teams and independently. You are...

  • Senior Mechanical Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with ExperienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring.​The ideal candidate is a self-starter who enjoys working within teams and independently. You are...

  • Senior Electrical Engineer

    6 days ago

    Warminster, United States LifeLens Technologies, LLC. Full time

    Job Description Job Description Salary: Commensurate with experience LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring. The ideal candidate is a self-starter who is collaborative, detailed oriented and goal driven. You excel at...

  • Senior Electrical Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.The ideal candidate is a self-starter who is collaborative, detailed oriented and goal driven. You excel at...

  • Senior Electrical Engineer

    7 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.The ideal candidate is a self-starter who is collaborative, detailed oriented and goal driven. You excel at...

  • MES Engineer

    6 days ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. We are seeking to hire an Enterprise Implementation / MES Engineer. The ideal candidate has...