NPD & CI Engineer — Medical Devices

Praxis Powder Technology, Inc.; Town of Queensbury (NY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance for $1/mo

Comprehensive Dental + Vision

401k matching up to 3%

Basic Life AD&D

Employee Assistance Program

Paid time off - 18 days first year

Paid holidays - 9 days

Annual performance bonus potential & 3

Profit sharing

Tuition assistance

Job summary

Praxis Technology in the United States is seeking a Development & Continuous Improvement Engineer to lead the qualification, transfer, and improvement of Praxis products and processes in a regulated manufacturing environment.

The role partners with Quality, Operations, Engineering, and Production to identify opportunities, solve problems, and deliver measurable improvements aligned with customer, regulatory, and business needs.

Qualifications

• Bachelors in Engineering or related technical discipline.
• 7+ years in new product development, manufacturing engineering, or process improvement in regulated manufacturing.
• Experience supporting NPD, process qualification, validation or transfer to production.
• Strong knowledge of Lean, Six Sigma, SPC, KPI development, RCA, and CAPA.
• Experience with Quality System Regulation, GMP, ISO 13485/9001 and/or AS9100 considered.
• Experience writing/revising production and quality procedures and related controlled documents.
• Excellent written and verbal communication; able to work independently and in teams.
• Detail-oriented with ability to manage priorities in a production environment.

Responsibilities

• Lead the successful transition of new products from development into full-scale manufacturing.
• Coordinate cross-functional project teams including Engineering, Quality, Operations, Supply Chain, and Customer Success.
• Develop and maintain project plans, timelines, and launch schedules for on-time implementation.
• Support prototype builds, pilot runs, validation activities, and production ramp-up.
• Create and maintain manufacturing documentation including work instructions, process flows, control plans, and SOPs.
• Drive process improvements through data analysis and performance measurement.
• Utilize root cause analysis tools including Fishbone diagrams and other corrective action methodologies.
• Evaluate equipment, tooling, fixturing, and resources needed for new launches.
• Perform risk assessments and proactively identify issues affecting project success.
• Collaborate with customers, suppliers, and internal teams to meet product requirements.

Skills

Lean manufacturing

Six Sigma

Statistical process control

CAPA

Root cause analysis

Data analysis

Quality system compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

MasterControl

Job description

Praxis Technology in the United States is seeking a Development & Continuous Improvement Engineer to lead the qualification, transfer, and improvement of Praxis products and processes in a regulated manufacturing environment.

The role partners with Quality, Operations, Engineering, and Production to identify opportunities, solve problems, and deliver measurable improvements aligned with customer, regulatory, and business needs.