New Product Development & Continuous Improvement Engineer

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

Are you ready to work for a company that truly cares about making a meaningful difference in this world?

A little about us:

Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets. We create sustainable flexibility that delivers maximum impact to make people’s lives better. It's pretty cool stuff!

We value people that are highly motivated, self-starters, open to learning new things every day. We look for like-minded individuals who will embrace the five core values of Praxis:

• Team player
• Driven to improve
• Genuinely care
• Dependable
• Own

What we can offer you:

In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our full-time employees:

• Employee and/or Employee + Child(ren) medical insurance for just $1/month!
• Comprehensive Dental + Vision
• 401k Retirement Plan that we match up to 3%
• Basic Life AD&D Insurance
• Employee Assistance Program
• Paid time off - 18 days first year (pro-rated)
• Paid holidays - 9days
• Annual Performance Bonus Potential & Profit Sharing Program
• Employee Profit Sharing
• Tuition Assistance
• We are currently unable to sponsor applicants for this role.

Position Summary

Reporting to the VP, Operations, the Development & Continuous Improvement Engineer supports the successful qualification, transfer, and improvement of Praxis products and manufacturing processes. This role leads and supports cross-functional initiatives related to new product development, process qualification, continuous improvement, CAPA, data analysis, KPI development, and quality system compliance. The Engineer partners with Quality, Operations, Engineering, and Production teams to identify opportunities, solve problems, reduce variation, strengthen processes, and deliver measurable improvements that support customer, regulatory, and business requirements.

The ideal candidate is a hands-on technical problem solver with strong engineering judgment, a commitment to quality, and a proven ability to execute projects in a regulated manufacturing environment. This individual must be able to work independently and collaboratively, communicate effectively across all levels of the organization, and demonstrate a positive, supportive, and continuous-improvement mindset.

How you will make an Impact

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

What You Must Bring to This Role

• Bachelor’s degree in Engineering or a related technical discipline required.
• 7+ years of experience in new product development, manufacturing engineering, or process improvement within a medical device, aerospace, or similarly regulated manufacturing environment required.
• Demonstrated experience supporting new product development, process qualification, validation, and/or transfer to production required.
• Strong working knowledge of Lean manufacturing, Six Sigma, statistical process control, KPI development, root cause analysis, risk evaluation, and CAPA tools required.
• Experience developing, analyzing, and presenting data to prioritize improvement opportunities and drive measurable results required.Working knowledge of Quality System Regulation, Good Manufacturing Practices, ISO 13485, ISO 9001, and/or AS9100 required.
• Experience writing and revising production procedures, quality procedures, engineering specifications, qualification protocols, reports, and related controlled documents required.
• Excellent verbal, written, interpersonal, and technical communication skills required.
• Proven ability to manage priorities, complete tasks proactively, work independently, and collaborate effectively in a team environment required.
• High attention to detail and ability to maintain focus in an active production environment required.
• Experience leading or supporting internal and/or external audits desired.
• Working knowledge of MasterControl or another electronic Quality Management System desired.

Working Conditions & Physical Efforts

• Work is performed in a production and office environment.
• May be exposed to standard manufacturing conditions, equipment, materials, and noise levels consistent with a regulated production facility.
• May be required to lift up to 50 lbs.
• Ability to stand, sit, walk, bend, reach, and move throughout the production area for prolonged periods of time.
• Visual functions include near vision, depth perception, and the ability to adjust focus.
• Talking and hearing occur frequently when communicating with leadership, team members, customers, vendors, and cross-functional partners.
• Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard and to operate applicable tools or equipment.
• Low exposure to physical risk when proper safety procedures and personal protective equipment requirements are followed.