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This position is responsible for designing and developing new and improved manufacturing processes and ensuring efficient and effective product transfer into production within the medical disposable devices industry.  Improve existing processes and implement new processes in the production line.

Job Responsibilities:

Develop and implement new manufacturing processes for production.

Perform Design of Experiments for process definition and optimize equipment parameters for new and/or existing processes.

Create documentation to support new and improved manufacturing processes.

Write and perform process validations (IQ, OQ, PQ) and validate methods for inspection, verification, and process controls.

Interface directly with assemblers, production supervisors, leads, and engineers.

Assesses process capabilities, innovates, and implements process improvements on key projects.

Applies technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.

Executes the functional deliverables associated with the NPI, Design Control, CAPA, and all Quality Systems.

As needed; plan, organize, and participate in all aspects of technical reviews.

Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOMs, Routers, FMEAs, etc.).

As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Principal Design Quality Assurance (DQA) Engineer, youll be at the heart of that mission to develop and support best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to develop MEE / MES. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

Your responsibilities include:
Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
May perform other duties as directed.

To Equipment Engineer will be responsible to engineer and implement highly capable & effective manufacturing equipment to meet business goals and objectives.

Key Responsibilities:
Responsible for developing testing and manufacturing equipment.
Create mechanical designs and drawings using Solidworks according to department standards and company procedures.
Ensure relevant documentation is prepared in line with all Quality and Regulatory guidelines and promotes full compliance with all GMP & E&AS
Identifying and solving the root cause of complex technical issues with production equipment.
Writing and execution of equipment qualifications, protocols, and reports.
Implementation of equipment into the production lines.