Project Manager for Technical Documentation

6 days ago

Saint Paul, Minnesota, United States Scanlan Int'l Full time
Job Description

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



  • 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

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.

Follow Quality Systems/Design Control Processes

40%



  • 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.

Design/Re-design/Document product and fixtures

10%



  • Design/re-design/document products and fixtures using Solid Works applying state of the art drafting standards.

QUALIFICATIONS

Required Qualifications:



  • 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.

Preferred Qualifications:

  • 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

  • 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, color 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, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

  • Technical Project Director

    6 days ago

    Saint Paul, Minnesota, United States Luminary Group Full time

    Luminary Group is a leading medical device business partner in the USA, seeking a skilled Technical Project Director to drive complex projects forward. As a key player, you will oversee technical direction and ensure successful project delivery.Responsibilities:Lead cross-functional teams, providing technical guidance, mentorship, and performance...

  • Technical Product Manager

    1 day ago

    Saint Paul, Minnesota, United States Scanlan Int'l Full time

    Job OverviewWe are seeking a highly skilled Technical Product Manager to join our team at Scanlan Int'l.About the RoleThis is a key position that requires strong technical knowledge, leadership skills, and excellent communication abilities. The successful candidate will be responsible for managing all technical and engineering documentation for assigned...

  • Technical Project Lead for Medical Devices

    6 days ago

    Saint Paul, Minnesota, United States Scanlan Int'l Full time

    We are seeking a skilled Technical Project Lead to join our team at Scanlan Int'l. As a key member of our engineering department, you will be responsible for managing technical projects from inception to completion.About the RoleThis is a full-time position offering a competitive salary range of $120,000 - $180,000 per annum, depending on experience.Key...

  • Documentation Specialist

    6 days ago

    Saint Paul, Minnesota, United States Randstad Life Sciences Full time

    Are you a skilled communicator with a passion for precision and clarity in the medical technology industry? We invite experienced Technical Writers to apply for this exciting opportunity with Randstad Life Sciences. This 6-month contract, potentially extendable, offers a HYBRID role, with onsite work on Tuesdays, Wednesdays, and Thursdays.About the RoleThis...

  • Environmental Project Coordinator

    6 days ago

    Saint Paul, Minnesota, United States Brown and Caldwell Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Environmental Project Coordinator to join our team at Brown and Caldwell.Salary RangeThe anticipated starting pay range for this position is between $27.70 - $38.00 per hour, depending on location and experience.Key ResponsibilitiesProject Delivery: Assist project managers in ensuring that all...

  • Medical Device Technical Writer with Hybrid Team

    5 days ago

    Saint Paul, Minnesota, United States LHH Recruitment Solutions Full time

    LHH Recruitment Solutions is seeking a talented Sr. Technical Writer to join their hybrid team for a 6-month contract position, potentially extending in Arden Hills, Minnesota.About the OpportunityThis role offers the chance to work on medical equipment manufacturing projects for a company with an excellent reputation. As a key contributor, you will be...

  • Water Project Manager Specialist

    4 days ago

    Saint Paul, Minnesota, United States Harrison Consulting Solutions Full time

    Our client, a reputable consulting firm in St. Paul, Minnesota, is seeking an experienced Potable Water Project Manager to join their team.The ideal candidate will have a strong background in potable water projects, with a minimum of 8 years of experience and a Professional Engineer (PE) license. They should be proficient in project management software and...

  • Project Management Leader

    1 day ago

    Saint Paul, Minnesota, United States Knobelsdorff Full time

    About the JobWe are seeking an experienced Project Management Leader to join our team. This is a unique opportunity to lead multiple solar projects simultaneously and contribute to the growth of our organization.Job Responsibilities:Plan and oversee project execution, ensuring timely completion and budget adherence.Manage project teams, allocate resources,...

  • Advanced Biomedical Technical Specialist

    7 days ago

    Saint Paul, Minnesota, United States Entegee Full time

    Job OverviewEntegee, a leading expert in custom automation projects and control solutions, is seeking an Advanced Biomedical Technical Specialist to join their team. This role will involve handling complaint documentation and medical device reporting (MDR) processes with a strong emphasis on technical writing and attention to detail.Salary InformationThe...

  • Field Support and Documentation Specialist

    1 day ago

    Saint Paul, Minnesota, United States CDM Smith Full time

    About CDM SmithAs a leading construction management and engineering firm, CDM Smith offers a unique opportunity to work on diverse projects and collaborate with experienced professionals.Job OverviewThis Field Support and Documentation Specialist role involves working closely with construction managers to ensure smooth project execution. You will conduct...

  • Technical Assistant

    5 days ago

    Saint Paul, Minnesota, United States Solventum Full time

    Join Our Team at SolventumWe are a dynamic company that pioneers game-changing innovations in healthcare, material science, and data science.Our team is passionate about creating breakthrough solutions for our customers' toughest challenges, improving lives, and enabling healthcare professionals to perform at their best.As a Technical Aid, you will have the...

  • Restoration Project Manager

    4 days ago

    Saint Paul, Minnesota, United States SERVPRO of St. Paul Central West Full time

    Job Title: Restoration Project ManagerLocation: St. Paul Central WestAbout the Role:We are seeking an experienced Restoration Project Manager to join our team at SERVPRO of St. Paul Central West. As a key member of our operations team, you will be responsible for overseeing restoration projects from start to finish.Key Responsibilities:Coordinate and manage...

  • Data Integration Specialist

    21 hours ago

    Saint Paul, Minnesota, United States C4 Technical Services Full time

    About this RoleC4 Technical Services is seeking a highly skilled Data Integration Specialist to join our team. As a Data Integration Specialist, you will be responsible for designing, developing, and implementing ETL processes using Informatica and SnapLogic tools.Key ResponsibilitiesDesign and develop ETL interfaces, workflows, sessions, and mappings in...

  • Document Control Specialist

    6 days ago

    Saint Paul, Minnesota, United States Schwing America Inc Full time

    Job DescriptionSchwing America Inc. is a dynamic and innovative company seeking a skilled Document Control Specialist to join our team.Job Summary:We are looking for a highly organized and detail-oriented individual to manage and maintain engineering documentation releases within our SAP ERP system. As a Document Control Specialist, you will be responsible...

  • Senior Biomedical Technical Writer

    7 days ago

    Saint Paul, Minnesota, United States Entegee Full time

    Job DescriptionA role that focuses on handling complaint documentation and MDR with a strong emphasis on technical writing and attention to detail.Key Responsibilities:Handle complaint documentation and MDR processes.Develop and maintain technical reports and documentation.Analyze and resolve issues related to medical device reporting.Ensure all reports and...

  • Technical Support Specialist

    6 days ago

    Saint Paul, Minnesota, United States Solventum Full time

    Solventum is a dynamic healthcare company that enables better, smarter, safer healthcare to improve lives. We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.About This RoleAs a Technical Aid at Solventum, you...

  • Renewable Energy Project Director

    4 days ago

    Saint Paul, Minnesota, United States Novel Energy Solutions LLC Full time

    Job DescriptionNoel Energy Solutions is a leader in the renewable energy sector, and we are seeking an experienced Project Manager to oversee the construction and maintenance of our projects.Key ResponsibilitiesOrganize and direct onsite construction activities to ensure timely completion and quality.Lead the construction effort from estimating to...

  • Senior Medical Device Project Manager

    1 day ago

    Saint Paul, Minnesota, United States Solventum Full time

    Job Title:Senior Medical Device Project ManagerAbout SolventumSolventum is a pioneering company that enables better, smarter, safer healthcare to improve lives. With a long legacy of creating breakthrough solutions for customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material, and data science. Our goal is...

  • Construction Materials Project Manager

    1 day ago

    Saint Paul, Minnesota, United States Harris Companies Full time

    Job DescriptionAs an Assistant Construction Materials Project Manager, you will play a vital role in ensuring the success of HVAC construction projects. Your primary responsibility will be to provide project management support during all phases of construction, from planning to completion.Key Responsibilities:Review and organize Contract Documents (drawings,...

  • Technical Aide Specialist

    5 days ago

    Saint Paul, Minnesota, United States Solventum Full time

    Join Solventum's Innovative TeamWe are seeking a talented Technical Aide to join our team at Solventum, a company that pioneers game-changing innovations in the healthcare industry. As a Technical Aide, you will have the opportunity to collaborate with senior researchers on assigned product/technology development projects and contribute to the success of our...