- 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.
- 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 Construction Files (TCF), 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 products and fixtures using Solid Works applying state of the art drafting standards.
- Occasional overnight travel may be needed for visiting vendors, supporting medical society meetings and for educational programs; must be capable of international travel.
- Must be comfortable meeting with industry professionals such as customers, vendors and physicians for the development and support of products.
- Must be comfortable viewing and discussing explicit medical procedures that may involve humans or animals for research studies.
- Must adhere to terms of Confidentiality to protect company's proprietary intellectual property, business practices, trade secrets and potential physician or hospital derived patient or procedural information (HIPAA).
- Bachelor's degree in Engineering, Sciences, or related discipline
- 5+ 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.
- Proficient with MS Office (Word, Excel, Outlook, OneNote), MS Project, Minitab
- Strong Verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Must be self-directed with sense of appropriate review and approvals.
- 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.
- 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)
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Project Engineer, Continuation - Saint Paul, United States - Scanlan Int'l
Description
Job Description
Job DescriptionThe Project Engineer professional is responsible for all technical and engineering documentation of their assigned projects. They plan, schedule, predict, and manage all the technical tasks for Scanlan Single-Use Devices and Re-Usable Surgical Instruments, to assure accuracy, proper resources, and quality through their product lifecycle. This includes Design and redesign of existing products; Maintaining technical documentation for Worldwide Distribution including FDA and CE Mark registration; Oversee routine sterilization; Maintain process validations for Sterilization, Packaging, Reprocessing and others; Lead cross functional teams and coordinate external resources; Author, organize and maintain test plans, protocols, and reports.
Position Responsibilities / Essential Functions:
Percentage Time
Accountability
45%
Product Support:
40%
Follow Quality Systems/Design Control Processes:
10%
Design/Re-design/Document product and fixtures
5%
Professionally represent the company with customers and vendors:
QUALIFICATIONS:
Required Qualifications:
Education:
Experience:
Skills:
Preferred Qualifications:
Experience:
Skills:
