Apex Systems is seeking a Senior Manufacturing Engineer/Project Manager to join our client, a global medical device manufacturer, in Milpitas, CA. This role will need to go on site 1-2 times a week and will work remotely the rest of the time.
For immediate consideration, please email a copy of your resume to Jenny DeMaria at [Click Here to Email Your Resumé] and reference Job ID #1163766.
Day to Day Responsibilities:
- Project Canyon/Project Phoenix
- Business is mostly with cataracts, surgical vision procedures and corrective surgeries
- Bring someone on to help run sub teams
- Mix of engineering, program management, good communication
- Getting into a lot of validation, qualification, etc for equipment and machines.
- Needs med device and FDA understanding
- Background: needs to come in from med device so they talk the same language with compliance, must have manufacturing experience and work in that space (do NOT want design engineers that have been working on floor), quality background could work. Need someone who is diverse enough to help with PM duties, like timelines, risk mitigation, planning activities.
Reporting to the Senior Project Lead, the Senior Manufacturing Engineer/Project Manager will be a team member who will possess a high degree of technical competency and project management skills to successfully lead their assigned sub-projects and extended cross-functional team members in pursuit of raw material objectives related to quality, delivery, cost, and design (e.g. changes, NPI introductions, etc.). The Engineer/Scientist will possess significant leadership skills enabling them to successful connect to cross-functional peers on and off-site and across the breadth of the organization in pursuit of delivery of this key strategy. The Engineer/Scientist key skills include validation, technical experience in molding, packaging and or regulatory submission. Preferred Medical Device background and the ability to understand technical requirements and ensure testing meets these requirements.
Essential Skills / Responsibilities
- Participates in the local cross-functional operational governance process that prioritizes projects across quality, delivery, and cost, assigns cross-functional resources for execution, and provides updates on assigned projects against commitments. Capable of leading in the absence of technical management as necessary.
- Can Lead and/or participates in a least three technical projects in parallel from the large and complex to smaller activities and tasks, utilizing appropriate Project Management / FPx tools and Six Sigma / Process Excellence tools. Delivers, through cross-functional coordination, not only the direct technical project activities but also all related regulatory, clinical, marketing, and other actions required to bring the project to market (e.g. a strong end-to-end mindset).
- Leads and/or participates in complex quality and failure investigations involving their project, partnering with the appropriate cross-functional resources and subject matter expertise as required, to identify root cause and implement corrective action. Communicates updates and progress and escalates appropriately.
- Provides guidance and input to leadership as it relates to the ability to maintain adequate support to meet delivery. Anticipates future constraints and raises, gains approval, and executes activities in advance of any constraints to ensure continuity of supply to customers.
- Employs their detailed knowledge of injection molding process parameters, tool / part design, assembly processes and techniques, LEAN/Six Sigma tools, and other engineering techniques to constantly identify, raise, gain approval, and execute, in collaboration with external and internal partners, to deliver improvement opportunities within the raw material supply chain against targets.
- Leads and/or participates in design changes to existing components and sub-assemblies, in partnership with appropriate design resources supporting lifecycle activities. Partners with R&D to delivery pFMEA’s/control plans, ensuring the receipt of a stable and capable process into sustaining engineering on-going lifecycle technical support.
- Leads and/or participates in projects across multiple manufacturing sites beyond Anasco and Santa Ana where common supply streams exist. Capable of engaging with cross-functional resources remotely and across time zones, cultures, and functions to deliver project objectives.
- As necessary, capable of managing all aspects of limited number of direct report resources and contractors assigned to the technical team, providing mentorship, guidance, and accountability.
- Maintains relationships with other Supplier Engineers and scientists as well as other company functions to engage subject matter expertise on assigned projects as required. Represents a strong technical voice to the suppliers and within the local Anasco and Santa Ana environment in support of the Project.
- Ensures the Project Lead is appraised of all aspects of assigned projects and other activities as risk, issues, urgency, and progress dictate.
- A minimum of a BS degree (or equivalent) in a technical discipline. An advanced degree is preferred. A professional engineering certification is preferred.
- 10+ years of relevant experience is desired.
- Demonstrated technical project management skills and experience (PMP/PMI certification, FPx certification, or equivalent preferred).
- Demonstrated Six Sigma / Process Excellence / LEAN skills and related tool usage (Belt Certification preferred).
- Significant experience in plastic injection molding processes, materials, part/tool design and systems, metrology equipment and inspection systems, GD&T, and related skills and technologies is required. A master molder certification is preferred.
- Demonstrated ability to clearly and concisely communicate across multiple organizational levels and functions, directly and remotely, and across global cultures.
- Some level of people management skills through either direct reporting relationships or project management relationships.
- Experience in a production environment and experience in a regulated medical industry and all related competencies (e.g. GMP, compliance, processes, etc.) is preferred.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178