Mechanical Engineer

4 weeks ago

Thousand Oaks, California, United States ACL Digital Full time
Job Title – Senior Engineer

Location – Thousand Oaks, CA – 91320 Onsite

Duration: 12 Months

Description:

ACL Digital is seeking a highly skilled Senior Engineer to join our team. As a Senior Engineer, you will play a critical role in the development and maintenance of our electromechanical systems.

Key Responsibilities:

  • Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
  • Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
  • Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
  • Establish experimental protocols, conduct experiments, analyze results
  • Support technical execution of Design History File (DHF) updates
  • Establish and maintain relationships with manufacturing site colleagues
  • Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
  • Establish and review specifications/requirements for components, products and processes
  • Support CAPA investigations
  • Ensures product conforms to current relevant international standards
  • Support multi-functional assessment of complaint record

Preferred Qualifications:

  • Bachelors degree in Engineering, Science or other technical degree
  • 1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
  • Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
  • Experience analyzing patient/user impact
  • Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards
  • Critical thinking, and problem-solving skills
  • An ability to work independently as well as a member of a team in a fast-paced environment
  • Working knowledge of statistical methods for data analysis
  • Familiar with microcontroller-based firmware, software verification (unit, static, dynamic analysis)
  • Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields
  • The position requires excellent organizational, technical problem solving and communication skills (written and verbal) and the ability to lead external teams

Basic Qualifications:

  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:

  • Medical device industry experience and regulated work environment experience
  • Medical Device Design Controls experience
  • Root cause analysis experience

  • Senior Mechanical Design Engineer

    4 weeks ago

    Thousand Oaks, California, United States RKS Design Full time

    Job Title: Senior Mechanical EngineerRKS Design is seeking an experienced Senior Mechanical Engineer to join our engineering and product development team. As a key member of our team, you will be responsible for designing and developing innovative mechanical solutions for consumer and medical products.Key Responsibilities:Lead complex projects from...

  • Senior Mechanical Engineer

    4 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job Title: Senior Mechanical EngineerJob Summary:ACL Digital is seeking a skilled Senior Mechanical Engineer to join our team. As a Senior Mechanical Engineer, you will be responsible for performing Sustaining Engineering activities of combination products with electromechanical delivery systems. This role will support the identification, review, assessment,...

  • Senior Mechanical Design Engineer

    3 weeks ago

    Thousand Oaks, California, United States RKS Design Full time

    Job DescriptionRKS Design has been a leader in Industrial Design in the United States for 40 years, delivering innovative product design and development services that enhance everyday lives across various market sectors.We are seeking an experienced team member to join our engineering and product development team. The ideal candidate will have at least five...

  • Senior Packaging Engineer

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job Title: Senior Packaging EngineerAmgen is seeking a highly skilled Senior Packaging Engineer to join our team. As a key member of our Packaging Engineering group, you will play a critical role in the development and implementation of packaging solutions for our pharmaceutical products.Key Responsibilities:Evaluate and recommend new packaging materials for...

  • Device Engineer

    4 weeks ago

    Thousand Oaks, California, United States Belcan Full time

    Job Summary:The Device Engineer will be responsible for participating in the design, development, and lifecycle management of commercialized drug delivery devices, including prefilled syringes. This includes technical operations support for failure investigations, leading and assessing design changes, test procedure development and execution, scale-up and...

  • Device Engineer

    3 weeks ago

    Thousand Oaks, California, United States Belcan Full time

    Job Title: Device EngineerJob Summary:Belcan is seeking a skilled Device Engineer to participate in the design, development, and lifecycle management of commercialized drug delivery devices. The successful candidate will be part of a device engineering team responsible for ensuring design history files are well-maintained and the client's delivery device...

  • Senior Packaging Engineer

    4 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Packaging Engineer to join our team at BioSpace, Inc. as a Senior Packaging Engineer - Materials Science Expert. In this role, you will be responsible for evaluating, designing, qualifying, and implementing packaging components and associated systems.Key Responsibilities:Evaluation and selection of new packaging...

  • Device Engineer

    4 weeks ago

    Thousand Oaks, California, United States Belcan Full time

    Job Title: Device EngineerWe are seeking a highly skilled Device Engineer to join our team at Belcan. As a key member of our device engineering team, you will be responsible for the design, development, and lifecycle management of commercialized drug delivery devices.Key Responsibilities:Participate in design center activities for commercialized drug...

  • Senior Plant Engineer

    3 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    About the Role:As a Senior Plant Engineer at BioSpace, Inc., you will be responsible for designing and implementing cost-effective projects and technologies within GMP plant systems in the Biopharmaceuticals manufacturing environment.You will focus on systems supporting cleanrooms and controlled environments in a commercially licensed biologics manufacturing...

  • Senior Plant Engineer

    4 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    About the Role:As a Senior Plant Engineer at BioSpace, Inc., you will be responsible for designing and implementing cost-effective projects and technologies within GMP plant systems in the biopharmaceuticals manufacturing environment. Your focus will be on systems supporting cleanrooms and controlled environments in a commercially licensed biologics...

  • Senior Product Development Engineer

    3 weeks ago

    Thousand Oaks, California, United States Katalyst HealthCares & Life Sciences Full time

    Job Summary: We are seeking a highly skilled Senior Product Development Engineer to lead our product development team in creating innovative medical devices. The ideal candidate will have a strong background in electrical/mechanical engineering and experience in project leadership in engineering product development, manufacturing, or research environments. ...

  • Product Development Engineering Manager

    1 week ago

    Thousand Oaks, California, United States Katalyst HealthCares & Life Sciences Full time

    Job Overview: At Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Product Development Engineering Manager to lead our medium to high complexity projects. As a key member of our team, you will be responsible for driving program execution, managing cross-functional teams, and ensuring successful device development of our mechanical and...

  • Senior Reliability Engineer

    3 weeks ago

    Thousand Oaks, California, United States Innova Solutions Full time

    Job Title: Senior Reliability EngineerJob Summary: We are seeking a Senior Reliability Engineer to join our team at Innova Solutions. As a Senior Reliability Engineer, you will be responsible for developing and overseeing the reliability of equipment while driving safety and quality compliance.Key Responsibilities:Develop and implement strategies to improve...

  • Quality Engineer

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Key ResponsibilitiesAs a Quality Engineer at Amgen, you will be responsible for providing technical expertise and oversight to ensure the design and development of medical devices meet regulatory requirements.Key responsibilities include:Providing quality technical expertise and oversight to design and development teamsEnsuring compliance with regulatory...

  • Senior Packaging Engineer

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job SummaryWe are seeking a highly skilled Senior Packaging Engineer to join our team at Amgen. As a key member of our Packaging Engineering group, you will be responsible for designing, qualifying, and implementing primary and secondary packaging components and associated systems.Your expertise in packaging materials science and engineering will be critical...

  • Reliability Engineering Specialist

    4 weeks ago

    Thousand Oaks, California, United States Insight Global Full time

    Job SummaryWe are seeking a skilled Reliability Engineering Technician to join our team at Insight Global. The ideal candidate will have a strong background in electromechanical systems and a passion for testing and troubleshooting.Key Responsibilities:Perform HBM and CDM testing on components to ensure they meet internal and industry standards.Conduct data...

  • Biopharmaceutical Process Engineer

    3 weeks ago

    Thousand Oaks, California, United States Aditi Consulting Full time

    Job Summary:The Facilities and Engineering group within Manufacturing and Clinical Supply organization at Aditi Consulting is seeking a skilled Biopharmaceutical Process Engineer to join their team. This role will report to the Senior Manager of Engineering and will be responsible for providing system ownership for Biopharmaceutical process equipment,...

  • Mechanical HVAC Project Manager

    4 weeks ago

    Thousand Oaks, California, United States EMCOR Group Full time

    Job Title: Project Manager IMesa Energy Systems, a subsidiary of EMCOR Group, Inc., is seeking a highly skilled Project Manager I to lead our HVAC mechanical services team.Job SummaryThe Project Manager I will be responsible for managing the overall operations of our contracts, including daily operations, scheduled maintenance, and administration of...

  • VCSEL Engineering Technician

    4 weeks ago

    Thousand Oaks, California, United States Teledyne Full time

    Job SummaryWe are seeking a highly motivated and dynamic individual to join our team as a VCSEL Engineering Technician. As a key member of our Laser Components & Systems group, you will be responsible for assembling and testing complex electro-optical systems, including Vertical Cavity Surface Emitting Lasers (VCSELs), in an advanced manufacturing and...

  • Cardiovascular Imaging Field Service Engineer

    1 week ago

    Thousand Oaks, California, United States Philips Full time

    Job Title: Cardiovascular Imaging Field Service EngineerPhilips is seeking a highly skilled Cardiovascular Imaging Field Service Engineer to join our team in the Los Angeles area. As a Field Service Engineer, you will be responsible for providing exceptional customer service by adhering to customer entitlements, setting clear expectations, and meeting...