Senior Process Development Engineer

Senior Process Development Engineer – Minnetronix Medical

A senior process development engineer leads technical development and evaluation of new manufacturing processes to support customer needs.

The senior process development engineer is responsible for technical leadership and timely development and evaluation of new manufacturing processes, providing expertise to internal clients and customers. Senior engineers may manage small to mid‑sized projects and direct reports.

• Process Concept
  :
  Propose new process/equipment/core technology improvement concepts; translate user and patient needs to process outputs; select improvements to increase UPH, yield, and manufacturability; participate in strategic planning; lead phase II and process quoting; guide process standards and best practices.
• Process Design & Development
  :
  Translate customer requirements into process outputs; plan and manage development and evaluation of assembly steps; perform risk assessment (FMEA) and DFMEA; manage process capability, DOE, and characterization studies; complete engineering documentation (MIPs, router/BOM updates) before verification and validation testing; participate in project planning and customer meetings.
• Verification & Validation
  :
  Manage qualification requirements and criteria based on Intricon and customer procedures; lead timeline planning and resource requests; prepare and release verification/validation protocols and reports (IQ, OQ, PQ); lead master validation plan development; collaborate across functions; develop documentation methodologies; communicate with customer to define validation strategy.
• Work Conditions
  :
  Use manual and light power tools; work in a development lab environment and office; be near a tool shop and controlled environment; travel to customer or vendors for project objectives.
• Working Through Others
  :
  Establish interdepartmental and interdivisional networks; understand laboratory, engineering, sales, and marketing interfaces; implement educational plans to maintain state‑of‑the‑art knowledge; participate in recruiting and staffing.

• Education
  :
  Bachelor’s degree in mechanical, chemical, bio‑medical engineering or similar field or equivalent experience.
• Experience
  :
  Minimum six (6) years of engineering experience in the medical device industry.
• Skills
  :
  Design controls and Quality System Regulations; strong verbal and technical writing; analytical and problem‑solving; interpersonal and communication skills; self‑initiator; full command of the product development cycle; coaching/mentoring; initiative to introduce new technologies; comfortable with ambiguity; curiosity for differing viewpoints.

Regularly use hands to finger, handle, or feel; stand, walk, sit, and talk or hear; reach with hands and arms; occasionally lift or move up to 25 pounds.

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

The salary range for this position is outlined in the job details and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package including health, dental, vision, 401(k) plans, and time‑off programs. Eligibility for an annual bonus program depends on individual and organizational performance.