Sustaining Manufacturing Engineer
Department: Research & Development
Reports to: Sr. Director of R&D or Sr. Sustaining Engineer
FLSA Status: Exempt
The Sustaining Engineer will be supporting cross-functional sustaining engineering project teams. This is an important role for the company, providing engineering expertise to support products already on the market. The position requires a team-oriented individual with strong engineering
and interpersonal skills.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned from time to time.
- Provide engineering expertise to cross-functional project teams.
- Support a portfolio of small to intermediate size sustaining engineering projects. Potentially lead smaller projects. Sustaining projects and activities typically originate from the following
areas, and include:
- Manufacturing support: Resolve supply chain issues, create supplier and component redundancy, perform design changes to reduce manufacturing cost, lead or support manufacturing line transfers.
- Supplier activities: Lead or support supplier changes to processes, design and/or materials. Resolve supplier issues.
- Quality: Develop test fixtures for the receiving inspection team, support audits, resolve CAPAs and NCRs, continuous improvement, remediation of existing design files to address changing regulations and/or changing test requirements.
- Pre-Market Regulatory: Support international registrations with product expertise and perform additional testing needed to meet country-specific requirements.
- Post Market Regulatory: Support complaint investigations, health hazard evaluations, field actions, IFU and labeling changes and regulatory assessments of design changes.
- Execute assigned projects and activities to agreed timelines.
- Create and update production level drawings for components and assemblies.
- Develop tooling and assembly methods for product/process changes.
- Perform design verification and process verification/validation.
- Build subject matter expertise in standard testing (aging and shipping studies, IEC 60601 etc.)
- Develop strong product knowledge to provide technical expertise to other functional areas.
- Perform gap analyses of existing design files due to new or changing regulations.
- Impact assessments to previous testing from design changes.
- Interface with customers and suppliers.
- Improve processes, always looking for more efficient and effective ways of achieving results.
- Individual must have a Bachelor of Science in Mechanical, Electrical, Biomedical, or other relevant engineering discipline from a four-year college or university.
- A minimum of 2+ years of experience (with progressively increasing responsibility) is required.
- Previous medical device (Class II or Class III) experience required (from product development, sustaining engineering or manufacturing engineering).
- Proficient in CAD, tolerance stack-ups and drawing reviews.
- Experience with a variety of manufacturing processes, for example machining, molding, joining, forming, additive manufacturing
- Understanding of plastic component injection molding and extrusion
- Medical device regulations experience
- Understanding of statistical process control
- Design control, change control and risk management experience (DFMEA, PFMEA)
- Design verification and process verification/validation protocol and report writing
- Experience from working with vendors.
- Project management skills
- Demonstrated problem solving skills
- High attention to detail
- Ability to effectively handle conflict through proactive action and direct and timely communication
- Excellent time management skills
- Good verbal and written communication skills
EMPLOYMENT WITH APYX MEDICAL
All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole absolute discretion.
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