Principal Process Development Engineer

As part of a multidisciplinary process development engineering team the Process Development Engineer will be responsible for engineering support in the definition, design, process development, and production transfer of a wide variety of medical devices. This role includes collaborating with internal engineers, operations, and key client stakeholders.

DUTIES AND RESPONSIBILITIES:

• Identify technologies that meet the manufacturing needs of new product development programs
• Define design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment
• Oversee vendor design and fabrication of automated manufacturing equipment
• Lead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.
• Represent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels
• Lead efforts for production release of finished goods and components. This includes BOM’s/routings and other ERP required information.
• Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area
• Manage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader
• Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes
• Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes
• Utilize project mgmt skills to drive process development, vendor adherence to program schedules, and validation projects to completion; on time and on budget
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
• Work with product development engineering to drive back lessons learned as new products are being developed
• Provide training and certification for trainers as required
• Lead efforts to investigate and develop new technology related to combination products

Requirements

QUALIFICATIONS:

• Bachelor’s Degree from a four-year college or university in Industrial Engineering, Mechanical Engineering or related field.
• Master’s Degree in Engineering is a plus
• 10+ years of experience, preferable in the medical device field.
• Design and manufacturing knowledge of plastics (extrusions, injection molding and/or precision parts), stamping, casting and/or sheet metal fabrication and/or: Experience in the design and development of interventional catheters.
• Demonstrated ability to collaborate with, support and direct mechanical design, review CAD models, part drawings and BOMs for accuracy and manufacturability.
• Experience directing small to medium size projects.
• Ability to work with electronic document and project management systems to track work product, deliverables and progress.
• Demonstrated ability to provide complete and accurate work product; material selection, designs, drawings and other documents that accurately reflect product requirements and transition smoothly into production.
• Strong work ethic and professional commitment
• The desire to both innovate and serve internal and external customers by meeting and exceeding project deliverables and timelines

Language Skills:

• Ability to write reports, business correspondence, or procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

Computer Skills:

• Should have knowledge of: SolidWorks, Office Suite

Preferred Qualifications:

• Working knowledge of data collection, data analysis, evaluation, and scientific method

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Salary Range for This Position: $140,000 - $160,000.

Nextern is an equal opportunity employer. We encourage