Senior Engineer-Drug Delivery/ Design Control

3 weeks ago

Thousand Oaks, United States Infotree Global Solutions Full time

Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm.


Candidates must have 5 years of experience.

Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and methodologies to support the various program Core Teams, including subteams within the Combination Product Operations function, to ensure projects deliverables are completed on time and adhere to high quality standards.


Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical 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. Responsible for tracking key project milestones and adjusting project plans to meet milestones on time. device design & development, s 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.


Responsible for driving program execution of various medium to large projects. Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan. This role leads across the Core Team to continuously integrate for predictable execution and teamwork across all functions.


Responsibilities:

· Lead medium/small projects independently and work directly with Program Manager on large multi-year programs.

· Managing the overall program including creating and maintaining the project schedule, identifying and mitigating program risks, driving program task execution, and co-leading regular core team meetings.

· 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.

· Co-Leads the cross-functional Program Core Team to establish an integrated plan for resources and materials to deliver the new product program per the Product Delivery Team commitment.

· 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.

· Works with the functional engineering leadership team to grow project leadership skills within the Core Team

· 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 :

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

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

3. 4+ years' experience in project leadership in engineering product development, manufacturing or research environment, including previous leadership of a global and/or virtual team.

4. 5+ years of more progressive responsibility and experience as an engineer or scientist

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

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

7. MS Project, One Pager, MS Teams, Smartsheet experience a plus


Top 3 Must Have Skill Sets:

Project management, design controls, drug delivery experience, risk based process

Combination product or medical device development experience.

Nice to have: Mechanical testing experience.

  • Senior Engineer-Drug Delivery/ Design Control

    3 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm. Candidates must have 5 years of experience. Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Senior Engineer-Drug Delivery/ Design Control

    3 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm. Candidates must have 5 years of experience. Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Senior Engineer-Drug Delivery/ Design Control

    3 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm.Candidates must have 5 years of experience.Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Senior Engineer-Drug Delivery/ Design Control

    2 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm. Candidates must have 5 years of experience. Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Senior Engineer-Drug Delivery/ Design Control

    3 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm.Candidates must have 5 years of experience.Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Senior Engineer-Drug Delivery/ Design Control

    2 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Hybrid position - in office times will differ from 1-3 days a week in office. 8-5pm.Candidates must have 5 years of experience.Responsible for coordination, status reporting and stability of Core Team project activities. Manages one or more cross-functional projects of medium to high complexity. Establishes and implements project management processes and...

  • Engineer Senior

    2 weeks ago

    Thousand Oaks, United States Crystal Equation Full time

    Engineer Senior Top 3 Must Have Skill Sets: Project management, design controls, drug delivery experience, risk based process Combination product or medical device development experience. Nice to have: Mechanical testing experience. Red Flags: Less t Engineer, Product Development, Project Lead, Program Manager, Mechanical, Senior, Technology, Staffing

  • Senior Engineer

    3 weeks ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Engineer

    1 week ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Senior Engineer

    3 weeks ago

    Thousand Oaks, United States Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...

  • Controls Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Principal Engineer/Controls Engineer / Automation Engineer Do you have the skills to fill this role Read the complete details below, and make your application today. Location: Thousand Oaks, CA 91320 Duration: 12+ Months Contract Basic Qualifications: Doctorate degree Master’s degree and 3 years of Manufacturing Automation Engineering experience...

  • Controls Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Principal Engineer/Controls Engineer / Automation Engineer Location: Thousand Oaks, CA 91320 Duration: 12+ Months Contract Basic Qualifications: Doctorate degree Masters degree and 3 years of Manufacturing Automation Engineering experience Or bachelors degree and 5 years of Manufacturing Automation Engineering experience Or Associate degree and 10...

  • Controls Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Principal Engineer/Controls Engineer / Automation Engineer Location: Thousand Oaks, CA 91320Duration: 12+ Months Contract Basic Qualifications:Doctorate degreeMaster’s degree and 3 years of Manufacturing Automation Engineering experienceOr bachelor’s degree and 5 years of Manufacturing Automation Engineering experienceOrAssociate degree and 10...

  • Controls Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Principal Engineer/Controls Engineer / Automation Engineer Location: Thousand Oaks, CA 91320Duration: 12+ Months Contract Basic Qualifications:Doctorate degreeMaster’s degree and 3 years of Manufacturing Automation Engineering experienceOr bachelor’s degree and 5 years of Manufacturing Automation Engineering experienceOrAssociate degree and 10...

  • Controls Engineer

    1 month ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Principal Engineer/Controls Engineer / Automation Engineer Location: Thousand Oaks, CA 91320Duration: 12+ Months Contract Basic Qualifications:Doctorate degreeMaster’s degree and 3 years of Manufacturing Automation Engineering experienceOr bachelor’s degree and 5 years of Manufacturing Automation Engineering experienceOrAssociate degree and 10...

  • Senior Automation Engineer

    34 minutes ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description: Job Responsibilities: 1) Manage day-to-day support of Client Drug substance operations 2) Represent plant automation team in Area WCTs 3) Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including...

  • Senior Automation Engineer

    2 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Job Responsibilities: 1) Manage day-to-day support of Client Drug substance operations 2) Represent plant automation team in Area WCTs 3) Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including...

  • Senior Automation Engineer

    1 month ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Job Responsibilities: 1) Manage day-to-day support of Client Drug substance operations 2) Represent plant automation team in Area WCTs 3) Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including...

  • Senior Automation Engineer

    2 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Job Responsibilities: 1) Manage day-to-day support of Client Drug substance operations 2) Represent plant automation team in Area WCTs 3) Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including...

  • Senior Automation Engineer

    2 weeks ago

    Thousand Oaks, United States Infotree Global Solutions Full time

    Description:Job Responsibilities: 1) Manage day-to-day support of Client Drug substance operations 2) Represent plant automation team in Area WCTs 3) Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including...