ACL Digital | Device Engineer

7 days ago

thousand oaks, United States ACL Digital Full time

Title: Senior Engineer

Location: Thousand Oaks, CA

Duration:12+Months


Description:

Hybrid - 3 days onsite


Hybrid role, candidate will be working primarily onsite at Amgen Thousand Oaks, with ability to work remotely

* Bachelors Degree in Engineering

* 5+ years of experience within Pharma, Biotech, Med Device



Responsible for planning, executing and reporting test activities for combination product teams. Coordinates with technical leads and cross functional teams to ensure deliverables needed for device design feasibility, characterization and verification stages are completed on time with high quality standards.




Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors. The qualified candidate will coordinate with technical teams to ensure successful device development of these medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.






Responsibilities:


Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.


Identifies early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals, execution adjustments/iterations, and cross-functional teamwork.


Works with the Program Manager to ensure effective and efficient communication and execution for the duration of the cross-functional program team.


Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget and with the necessary features/functionality.


Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers.




Qualifications/Requirements :


Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience


Medical device and/or combination product development experience; design controls experience


5+ years of more progressive responsibility and experience as an engineer or scientist


Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills


Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies


Familiarity with test equipment such as Instron.

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

Max Rate Not to Exceed (If this differs from the job posting template):


Top 3 Must Have Skill Sets:

Testing experience

Product Development

Experience with design controls and medical device regulations

Drug delivery/combination product experience

risk based process

presentation skills


Day to Day Responsibilities:

Author device documentation to support development, planning, verification, validation, and transfer

Author test protocols and execute mechanical testing of drug delivery devices

Presentation and communication skills (within program teams)

Execute and deliver within regulated development processes

Proactively maintains close communication with technical leads


Create and maintain project timelines

  • ACL Digital | Process Engineer

    7 days ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Project EngineerLocation: Thousand Oaks CADuration: 12 MonthsDescription:MUST BE LOCAL TO Amgen Thousand Oaks. Staff should be a Flexible Commuter. Staff may be required to be onsite as needed based on business needs and can expect to be onsite on a weekly basis.Ideal candidate: The ideal candidate for this role should have a bachelor’s degree...

  • Device Engineer for GMP Regulated Environment

    4 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    At ACL Digital, we offer a competitive salary of $120,000 annually to our Device Engineer. 100% Thousand Oaks-based role open to relocation candidates with standard shift hours from 8-5pm and potential for overtime. Ideal candidate has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement...

  • ACL Digital | Process Engineer | thousand oaks, ca

    3 weeks ago

    thousand oaks, United States ACL Digital Full time

    Job Title : Engineer100% Onsite Thousand oaksContract roleIdeal candidate: Experience as a process engineer or similar role in equipment ownership. Strong reliability background and independence in problem-solvingCapable of networking with other buildings and teams to implement reliability programs. Tools include Excel, JMP, and basic knowledge of Python...

  • Device Engineer

    1 week ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Senior EngineerLocation: Thousand Oaks, CADuration:12+MonthsDescription:Hybrid - 3 days onsiteHybrid role, candidate will be working primarily onsite at Amgen Thousand Oaks, with ability to work remotely* Bachelors Degree in Engineering* 5+ years of experience within Pharma, Biotech, Med DeviceResponsible for planning, executing and reporting test...

  • ACL Digital | Project Engineer | thousand oaks, ca

    3 weeks ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Project EngineerLocation: Thousand Oaks CADuration: 12 MonthsDescription:MUST BE LOCAL TO Amgen Thousand Oaks. Staff should be a Flexible Commuter. Staff may be required to be onsite as needed based on business needs and can expect to be onsite on a weekly basis.Ideal candidate: The ideal candidate for this role should have a bachelor’s degree...

  • Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    100% Thousand Oaks Open to relocation candidates Standard shift 8-5pm potential for OT. Ideal Candidate: has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries,...

  • Process Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title : Engineer100% Onsite Thousand oaksContract roleIdeal candidate: Experience as a process engineer or similar role in equipment ownership. Strong reliability background and independence in problem-solvingCapable of networking with other buildings and teams to implement reliability programs. Tools include Excel, JMP, and basic knowledge of Python...

  • Process Engineer

    2 months ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract) Job ID: AMAGJP00013357 Location: Thousand Oaks, CA(Hybrid) Description:Notes from manager: Needed candidates with Tech transfer and Combination Product(CP)/Final drug product(FDP) experience.Onsite Thousand Oaks - 3 days a week.Schedule is typically 8am - 5pmsome flexibility with schedule, may be expected to work OT...

  • Process Engineer

    2 months ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract) Job ID: AMAGJP00013357 Location: Thousand Oaks, CA(Hybrid) Description:Notes from manager: Needed candidates with Tech transfer and Combination Product(CP)/Final drug product(FDP) experience.Onsite Thousand Oaks - 3 days a week.Schedule is typically 8am - 5pmsome flexibility with schedule, may be expected to work OT...

  • Process Engineer

    2 months ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract) Job ID: AMAGJP00013357 Location: Thousand Oaks, CA(Hybrid) Description:Notes from manager: Needed candidates with Tech transfer and Combination Product(CP)/Final drug product(FDP) experience.Onsite Thousand Oaks - 3 days a week.Schedule is typically 8am - 5pmsome flexibility with schedule, may be expected to work OT...

  • Project Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Project EngineerLocation: Thousand Oaks CADuration: 12 MonthsDescription:MUST BE LOCAL TO Amgen Thousand Oaks. Staff should be a Flexible Commuter. Staff may be required to be onsite as needed based on business needs and can expect to be onsite on a weekly basis.Ideal candidate: The ideal candidate for this role should have a bachelor’s degree...

  • Senior Software Development Specialist

    4 weeks ago

    Thousand Oaks, California, United States ACL Digital Full time

    Job SummaryACL Digital is seeking a highly skilled Specialist Software Engineer to join our team. The ideal candidate will have a strong background in software development, with expertise in Planisware and Agile methodologies.Key Responsibilities• Collaborate with the resource management team in designing, developing, and supporting Planisware-based...

  • Engineer

    2 months ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract)Location: Thousand Oaks, CAONSITE AT THOUSAND OAKS CAM.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like...

  • Engineer

    2 months ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract)Location: Thousand Oaks, CAONSITE AT THOUSAND OAKS CAM.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like...

  • Engineer

    2 months ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract)Location: Thousand Oaks, CAONSITE AT THOUSAND OAKS CAM.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like...

  • Engineer

    2 months ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Engineer (Long Term Contract)Location: Thousand Oaks, CAONSITE AT THOUSAND OAKS CAM.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like...

  • Process Engineer

    1 week ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Process EngineerLocation: Thousand Oaks, CADuration: 12 Months Description:Onsite 3-4 days/week at Thousand Oaks, CA Top 3 Must Have Skill Sets:Specifically looking for downstream purification experience**Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)GMP experience...

  • Engineer Principal

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Fully onsite Thousand Oaks, CA 2 Openings Copy of former posting AMAGJP00012201 (previous supplier call notes- top 3 must haves- GMP, life sciences, automation experience. Looking for 3-5 years industry experience) Scrubbed resume attached Client Job Description: Global leader in the Biotechnology industry is seeking a professional Principal Automation...

  • Senior Automation Engineer

    2 months ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer Principal (Long Term Contract)Location: Thousand Oaks, CA (Fully Onsite) Description: Fully onsite Thousand Oaks, CA 2 OpeningsCopy of former posting AMAGJP00012201 (previous supplier call notes- top 3 must haves- GMP, life sciences, automation experience. Looking for 3-5 years industry experience) Job Description:Global leader in the...

  • Senior Automation Engineer

    2 months ago

    thousand oaks, United States ACL Digital Full time

    Job Title: Engineer Principal (Long Term Contract)Location: Thousand Oaks, CA (Fully Onsite) Description: Fully onsite Thousand Oaks, CA 2 OpeningsCopy of former posting AMAGJP00012201 (previous supplier call notes- top 3 must haves- GMP, life sciences, automation experience. Looking for 3-5 years industry experience) Job Description:Global leader in the...