Sr. Development Engineer

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world

Job Title: Sr. Development Engineer
Location: Warsaw, IN 46580
Duration: 7 Months
Job Type: Temporary Assignment
Work Type: Remote

Job Description

Summary

We are seeking a Sr. Development Engineer to support post-market activities for existing Design History Files (DHFs) related to medical devices. This role will be responsible for reviewing and updating DHF documentation, supporting risk management activities, conducting design reviews, and developing verification and validation strategies. The ideal candidate will possess a strong background in medical device design controls, technical documentation, risk analysis, and cross-functional collaboration within regulated environments.

Responsibilities

• Author and review existing Design History Files (DHFs) and identify documentation gaps where required records are missing.
• Utilize Vault systems to manage document workflows and support documentation control processes.
• Generate, analyze, and update risk management documentation including DFMEAs and risk assessment tables.
• Coordinate, prepare, and facilitate design reviews with cross-functional stakeholders.
• Perform Functional Relationship Analyses (FRA) and tolerance stack-up evaluations.
• Develop protocols and test strategies for design verification and validation (V&V) activities.
• Review and update engineering drawings, prints, and manufacturing documentation.
• Collaborate with Regulatory Affairs, Quality, Manufacturing, and Engineering teams to ensure compliance with medical device design control requirements.
• Support remediation and maintenance activities for existing product design history files.
• Ensure project deliverables are completed within established timelines and quality standards.

Required Skills

• Strong experience with Design History File (DHF) documentation for medical devices.
• Experience with Vault Systems and document management workflows.
• Knowledge of Design Control requirements within regulated medical device environments.
• Experience generating and maintaining DFMEAs and risk management documentation.
• Familiarity with drafting standards and Geometric Dimensioning and Tolerancing (GD&T).
• Experience conducting design reviews and engineering assessments.
• Ability to perform Functional Relationship Analysis (FRA) and tolerance stack-up studies.
• Strong technical writing and documentation skills.
• Proficiency with Microsoft Office Suite.
• Excellent communication, organizational, and teamwork skills.
• Self-motivated with the ability to work independently and manage multiple priorities.

Preferred Skills

• Experience supporting post-market medical device projects.
• Familiarity with regulatory requirements and quality system processes.
• Experience collaborating with Regulatory and Quality organizations.
• Knowledge of design verification and validation methodologies.
• Experience working within cross-functional product development teams.

Education

• Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, Materials Engineering, or related engineering discipline from an ABET-accredited institution or equivalent.

Experience

• Demonstrated experience in medical device product development and design control activities.
• Experience authoring, reviewing, and maintaining Design History Files.
• Experience supporting risk management, design verification, and validation activities.
• Proven ability to support complex engineering projects within regulated environments.

Certifications

• No specific certifications required.
• Relevant engineering, quality, or medical device certifications are considered a plus.

TekWissen Group is an equal opportunity employer supporting workforce diversity.