Sr. Manufacturing Engineer
The Senior Manufacturing Engineer is responsible for development and implementation of equipment and processes for manufacturing of single-use disposable, energy based surgical devices. This role is an integral part of the product development team and will provide manufacturing expertise to the design and development engineers throughout the entire product lifecycle.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned from time to time.
- Participate in product development teams with specific responsibility for developing robust and capable manufacturing processes, ensuring R&D and Operations needs and targets are met
- Process innovation with emphasis on improving quality, reducing process variation, reducing cycle time and cost reduction initiatives.
- Lead equipment, fixture and process development, process characterization and process qualification to support new product development and introduction.
- Partner with design and development engineers to identify Design for Manufacturability and Assembly (DFM/DFA) targets
- Successfully complete all the Process Development project elements by the milestone dates
- Ensure process capability and yield targets are met
- Hands-on development of manufacturing processes
- Provide guidance, coaching and training to other employees within the team. Drive results on project teams, through building relationships and strong technical decision making.
- Provide mentoring and direction to more junior technical staff
- Present status of plans and projects to company management
- Networks with senior internal and external personnel to facilitate cross-functional teamwork
- May lead small project team for process development or manufacturing problem solving
- Develop aggressive but realistic project timelines
- Accountable for effective transfer of design to manufacturing.
BS degree in Mechanical, Manufacturing, or Industrial Engineering (or other relevant technical/scientific discipline)
- A minimum of 5+ years of experience, with progressively increasing responsibility, in process development/manufacturing engineering.
- Previous medical device manufacturing experience required
- Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, PPQ)
- Working knowledge of PFMEAs, sampling plans, normality and capability assessment
- Process validation protocol and report writing
- Working with vendors. Plan and help execute vendor Process Qualifications
- Experience with a variety of manufacturing processes, for example machining, molding, joining forming, additive manufacturing
- Designing equipment and fixtures using CAD software, including performing tolerance stack-ups
- Experience with Lean principles and their implementation
- Six Sigma training
- Knowledge of GD&T
- Experience from scaling manufacturing processes
- Working knowledge of statistical tools such as DOE, Statistical Process Control, Hypothesis Testing and Process Capability Studies
- Experience with statistics software packages, for example Minitab
- Understanding of DFSS, DFM and Design for Lean activities in the early phase of new product design
- Experience in project management and leading small teams
- Ability to identify and resolve issues without direct supervision
- Demonstrated problem solving skills
- History of successfully transferring projects to manufacturing
- Excellent organizational skills and 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
- Leadership and self-starter qualities
- Ability to prioritize workload, meet multiple deadlines simultaneously in a fast -paced environment
- Experience with manufacturing of single use disposable medical devices
- Background in electrosurgical devices (or other energy based surgical devices)
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 and absolute discretion.
Join the team where we offer a rewarding work experience, compensation and benefits package. Salary is commensurate with professional experience. For immediate consideration, please forward your resume, along with salary requirements, to: Amy Cascio, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760-4004 or e-mail firstname.lastname@example.org
APPLYING FOR EMPLOYMENT
If you are interested in becoming a member of the Apyx™ Medical team, you may download our Employment Application PDF, fill it out, and send it along with your resume using any of the following methods:
EMAIL OUR HUMAN
MAIL A HARD COPY
c/o Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004