Job Information
Actalent Sustaining Engineer in Camarillo, California
Job Title: Project Manager - Technical Leadership in New Product IntroductionsJob Description
We are seeking a highly skilled Project Manager to provide technical leadership during the commercialization and post-commercial improvement phases of new product introductions. This role includes product validation, process optimization, and cost reductions. The ideal candidate will lead problem-solving initiatives, support sourcing and supplier quality, drive product and process change management, and specify and qualify capital equipment.
Responsibilities
Lead problem-solving, corrective, and preventative actions for product and manufacturing process concerns.
Support sourcing of new items and supplier quality.
Drive and facilitate product and process change management and control.
Specify and qualify capital equipment.
Author and update technical and process documentation as required.
Develop deep product knowledge to provide technical expertise to other functional areas.
Analyze mechanical designs, including technical drawings and associated measurement systems.
Plan and conduct product verification and validation testing, and lead production transfer of new products.
Work with Design Engineering and Manufacturing to integrate a Design for Manufacture & Assembly and Design to Cost perspective during verification.
Drive capital equipment requests and qualification.
Conduct labor and process studies, lead yield improvements, reduce variability, support manufacturing in resolving technical problems, and lead product cost reduction initiatives.
Perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
Support customer complaint investigations, analyze complaint data to identify and address systemic design issues, propose design changes, manage implementation, and monitor effectiveness.
Support audits, resolve CAPAs and NCRs, continuous improvement, and remediation of existing design files to address changing regulations and test requirements.
Provide engineering support for product compliance (REACH, ROHS, etc.).
Create supplier and component redundancy, perform design changes to reduce material and manufacturing costs, lead-times, and quality issues.
Lead or support supplier changes to processes, design, and/or materials. Resolve supplier issues.
Drive full documentation of design including BoM, drawings, engineering change control, and procedures.
Ensure process and design changes are documented and adhere to industry quality standards.
Interact with key company personnel and external partners related to product design and manufacturing.
Develop and maintain positive rapport and working relationships with other personnel across the organization.
Essential Skills
Bachelor's degree in Engineering; Master's preferred.
8+ years of hands-on design and development in plastic design and manufacturing or related industry.
Experience with design verification, process verification/validation protocol, and report writing.
Design control, change control, and risk management experience (DFMEA, PFMEA).
In-depth knowledge of creating 2D and 3D drawings and related Bill of Materials.
Ability to repurpose existing technologies or create new innovations to solve problems.
Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (CAPAs).
Strong project management, organizational, and time management skills. Detail and deadline-oriented.
High initiative with the ability to work independently and problem solve with minimal supervision.
Strong work ethic and effective communication skills, both verbal and written.
Strong interpersonal skills to interact with staff at all levels within and external to the organization.
Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.
Ability and willingness to travel up to 10%, including occasional international travel.
Additional Skills & Qualifications
Single Use Consumable design and development experience.
Experience working with multiple bioprocessing equipment suppliers.
Biotech device development experience.
Process characterization experience applying Design of Experiments to optimize manufacturing processes.
Statistical Process Control (SPC) experience.
Work Environment
The work environment includes working in a GMP or laboratory setting. The role may require travel up to 10%, including occasional international trips. Interactions with key company personnel and external partners are essential, fostering a collaborative and supportive workplace culture. Professional attire is expected.
Pay and Benefits
The pay range for this position is $90000.00 - $125000.00
Sure! SaniSure offers a range of benefits to support the well-being and financial security of its employees. These include health insurance options, life and disability coverage, a retirement savings plan with employer contributions, and paid time off. Additionally, they provide resources for emotional health and well-being through an employee assistance program.
Workplace Type
This is a fully onsite position in Camarillo,CA.
Application Deadline
This position will be accepting applications until Jan 23, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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