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.
