Mechanical Engineer
Consultant, Mechanical Engineer, Design History Files/Design Controls, Medical Device
Summary
Our client, a global medical device firm, a mechanical engineer to assist with a DHF remediation of a recent acquisition. This role will support large scope projects, multiple projects, and/or projects of significant strategic importance to the business. Responsible for the design, development, and qualification of electromechanical instruments.
Duties / Expectations of Role
· Supports the DHF remediation project. Identifies all tasks required to complete project assignments according to Design Control procedures. Prepares work plans outlining estimated manpower requirements and development costs.
· Designs for reliability, regulatory compliance, manufacturability, inspectability and optimum cost
· Participates in root cause analysis for problem solving
· Contributes to generation of a comprehensive protocol for testing/analyzing the product
· Prepares definitive new product specifications or modifies existing specifications
· Generates or updates design control documentation for products. Completes factors/Usability documentation for new or existing designs.
· Generates and/or manages the creation of prototype models to evaluate new design concepts
· Possibility of assisting with the validation and writing of software applications for the products
· Responsible for collecting and assessing existing design documents, and to perform a gap analysis of the DHF/Design documentation based on current regulatory agencies' guidelines regarding design control.
· Responsible for organizing an electronic repository and presenting it to appropriate Subject Matter Experts in order to assume a proper knowledge transfer.
· Assist with collection of existing design control documentation and establish an electronic repository for the organization of this documentation in compliance with applicable regulations governing the medical device industry, including but not limited to FDA regulations.
· Review design control activities for existing products including planning, risk assessment, design development, design verification and validation, design review, design change and documentation for design history file.
· Act as liaison with other departments to support design control review activities.
· Review (for accuracy and completeness) verification and validation data, including reports, spreadsheets, statistical summaries, for incorporation into project documentation.
· Perform a full assessment of on-market DHF/design documents to determine gaps and establish protocols to remediate identified gaps.
Mandatory Requirements
· Mechanical Engineering degree
· Minimum 3-5 years of experience in Design and Development related position either in development or R&D department in an FDA regulated Industry.
· Full working knowledge of and moderate level of experience with new product development in medical devices, particularly electromechanical device
· Basic Project Management Skills
· Familiarity with various electromechanical standards and testing, including IEC 60601
· Demonstrated ability to methodically investigate, determine appropriate solution and resolve significantly complex problems using current technology
· Ability to process engineering changes and make recommendations based upon business principles
· Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors.
· Demonstrated good written and verbal communication skills including presentation skills
· Working knowledge of drafting standards and geometric dimensioning and tolerancing
· Experience with DHF Remediation Projects
· Must be familiar with current Design Control guidelines.
· Team player (displays enthusiasm, confidence & commitment).
· Microsoft Office Suite and Project
· Ability to take initiatives and work independently.
Nice to Have Requirements
· Software as a Medical Device Experience (SaMD)
· Experience validating and writing software
· EUMR Experience
Term & Start
· 18 months contract
· Northern Ohio or Northern California
· Remote work is a possiblity