Product Engineer II
1 month ago
JOB DESCRIPTION
As a Process Development Engineer II, you will develop new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working to drive continuous yield improvement.
Responsibilities will include but are not limited to:
Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for yield improvement projects through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.
Develop fixtures, tooling, and equipment.
Develop process specifications which ensure user needs are met.
Perform process characterizations and qualifications (IQ/OQ/PQ).
Manage required builds for yield improvement projects in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.
Comply with applicable FDA and international regulatory laws/standards.
Perform other duties as assigned or required.
Nice to Have
2+ years of experience developing products and/or manufacturing processes in the medical device industry
Knowledge of SolidWorks and engineering statistics
Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, braiding, crimping, swaging, cleaning processes, etc.
Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).
Knowledge of design and process FMECA, process validation, and process control.
Knowledge of design for manufacturability and lean methodologies.
Top 3 technical skills that are required for the role:
Validations
Project Planning
Technical Writing
Education Required:
Bachelor’s degree in Engineering (preferably Mechanical, Electrical, or Biomedical)
Years’ Experience Required:
2+ years of experience developing products and/or manufacturing processes in the medical device industry.
Will the contractor be working 40 hours a week? Will there be any overtime required?
Yes, 40hrs p/w with the potential of overtime.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Onsite fulltime
What is your timeline for scheduling interviews?
Within the next two-three weeks
What product line will this person support?
Sphere-9 Disposables
Responsibilities may include the following and other duties may be assigned. Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints. Assumes responsibility for device after transfer into highvolume production and usually responsible for entire device manufacturing operations other than wafer fabrication. May assist customer in device usage problems or customer testing of complex devices. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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