Sr. Development Engineer

Creative Solutions Services, LLC; Warsaw (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC seeks a DHF Documentation Specialist to manage and author design history files for medical devices. You will utilize Vault for document workflow, review risk documentation, and coordinate design reviews with Regulatory and Quality teams.

The role emphasizes technical writing, GD&T familiarity, and effective cross-functional collaboration to expedite critical project tasks and maintain compliance.

Qualifications

• Familiarity with Vault Systems
• Familiarity with drafting standards and GD&T
• Strong DHF documentation authoring background for Medical Devices
• Ability to work with cross-functional teams incl. Regulatory and Quality
• Establish process methods meeting performance and quality requirements
• Ability to give clear and concise oral presentations
• Technical writing
• Microsoft Office Suite

Responsibilities

• Author and review existing DHF, identify scope and gaps
• Utilize Vault Systems to manage document workflow
• Generate or analyze risk documentation (DFMEA or risk tables)
• Coordinate, prepare, and conduct design reviews with cross-functional teams
• Perform FRA and tolerance stack-ups
• Generate protocols to test/analyze product for V&V
• Update prints and other design/manufacturing elements

Skills

Strong communication

Teamwork

Oral presentations

Technical writing

Microsoft Office Suite

Education

ABET-accredited B.S. in Biomedical, Mechanical, or Materials Engineering

Tools

Vault Systems

Drafting standards knowledge

Job description

Summary:

• Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager.


• Previous system experience with Vault is preferred.


• Excellent communication, teamwork, and organizational skills are essential.


• Candidates must be self-starters and self-motivators. .

Roles and Responsibilities:

• Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing


• Utilize Vault Systems to manage Document workflow


• Generate or analyze and update existing risk documentation (DFMEA or risk tables)


• Coordinate, prepare, and conduct design reviews with cross-functional teams


• Perform functional relationship analyses (FRA) and tolerance stack-ups


• Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)


• Update prints and other design and manufacturing elements

Requirements:

• Familiarity with Vault Systems


• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)


• Strong Background in DHF documentation authoring and executing for Medical Devices


• Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality


• Establishing a process method which meets performance and quality requirements


• Ability to give clear and concise oral presentations


• Technical writing


• Microsoft Office Suite


• B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.