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 applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.