Demo

Project Engineer

Energy Jobline AZ
Saint Paul, MN Full Time
POSTED ON 1/23/2025
AVAILABLE BEFORE 4/23/2025

The Project Engineer is responsible for managing all technical and engineering documentation for their assigned projects. This role involves planning, scheduling, predicting, and overseeing all technical tasks related to Scanlan Single-Use Devices and Re-Usable Surgical Instruments to ensure accuracy, resource allocation, and quality throughout the product lifecycle. Key responsibilities include :

A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible.

  • Designing and redesigning existing products
  • Maintaining technical documentation for global distribution, including FDA and CE Mark registration
  • Overseeing routine sterilization processes
  • Maintaining process validations for sterilization, packaging, reprocessing, and other procedures
  • Leading cross-functional teams and coordinating with external resources

Position Responsibilities / Essential Functions :

Percentage Time Accountability

  • 50% Product Support : Ensure products remain in conformance with US, EU, and rest of world regulatory requirements by developing test plans, protocols, and reports necessary to provide evidence of conformity. Lead design assurance teams including engineers for Human Factors, Biocompatibility, Packaging, Risk, Sterilization, and Manufacturing through product design, re-design, development, design transfer and Post Market Surveillance (PMS) activities. Oversee production sterilization activities to ensure products may be released to the market. Drive test method development and validation efforts with the test group including identification of applicable standards and guidance, establish acceptance criteria and approve results. Perform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state of the art. Take Responsibility for the Risk Management process. Write, edit, and maintain risk management plans / reports risk assessment (FMEA's) and hazard analysis. Provide engineering support in the trouble shooting of manufacturing process with manufacturing partners.
  • 40% Follow Quality Systems / Design Control Processes : Coordinate, draft and maintain documentation in support of ISO 13485 and FDA 820 quality systems including design control; such as Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Technical Files (TF's), Work Instructions (WI), Manufacturing Procedures (MP), Bill of Materials (BOM), Etc. Investigate product complaints; Participate in Corrective Actions / Preventative Action process. Facilitate identification of root cause for quality and clinical issues that arise for current products.
  • 10% Design / Re-design / Document product and fixtures : Design / re-design / document products and fixtures using Solid Works applying state of the art drafting standards.
  • QUALIFICATIONS :

    Required Qualifications :

  • Education : Bachelor's degree in engineering, sciences, or related discipline
  • Experience : 5 - 8 years of related work experience in a similar role within a regulated industry (i.e., medical device, Pharmaceutical, Aerospace, etc.), including quality management system (QMS) experience. Three (3) years' experience (intermediate level) using CAD 3D modeling (SolidWorks) producing engineering drawings from CAD models including dimensioning, use of tolerances and inspection features.
  • Skills : Proficient with MS Office (Word, Excel, Outlook, OneNote), MS Project, Minitab. Ability to demonstrate experience managing projects from inception to completion. Excellent time management and project organization skills. Strong communication and interpersonal skills, with ability to effectively collaborate at multiple levels in the organization, clients and stakeholders. Must be self-directed with sense of appropriate review and approvals.
  • Qualifications :

  • Experience : Experience with single-use device Packaging and Sterilization (gamma and ETO) maintenance and validations. Experience with re-usable device Reprocessing (cleaning, thermal disinfection, steam sterilization). Experience with Biocompatibility. Experience with Risk Management. Design knowledge and / or processing experience with materials and processes such as : stainless steel, titanium, nitinol, thermal plastics, silicone including extrusion, molding, machining, forging, heat treating, plating, welding, passivation, and electro-polishing. Experience with CE Mark products.
  • Skills : Ability to apply statistical methods and tools including : Determine sample size; Establish confidence and reliability levels necessary with sound justification; Develop capability and / or process validation plans with statistically sound sample sizes and analysis. Geometric Dimensioning and Tolerancing (GD&T).
  • Physical Demands :

    The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the associate is regularly required to stand, walk, sit and use hands to manipulate, handle, or feel objects, tools, controls, manufacturing equipment and office equipment. The associate frequently is required to talk and hear. The associate must occasionally lift and / or move up to 20 pounds. Specific vision abilities required by this job include close vision, vision and ability to adjust focus.

    Work Environment :

    The work environment characteristics described herein are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or status as a protected veteran.

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