[Hiring] Senior Development Engineer @TekWissen

Role Description

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:

• Authoring and reviewing existing Design History Files (DHFs) and identifying documentation gaps.
• Utilizing Vault systems to manage document workflows and support documentation control processes.
• Generating, analyzing, and updating risk management documentation including DFMEAs and risk assessment tables.
• Coordinating, preparing, and facilitating design reviews with cross-functional stakeholders.
• Performing Functional Relationship Analyses (FRA) and tolerance stack-up evaluations.
• Developing protocols and test strategies for design verification and validation (V&V) activities.
• Reviewing and updating engineering drawings, prints, and manufacturing documentation.
• Collaborating with Regulatory Affairs, Quality, Manufacturing, and Engineering teams to ensure compliance with medical device design control requirements.
• Supporting remediation and maintenance activities for existing product design history files.
• Ensuring project deliverables are completed within established timelines and quality standards.

Qualifications

• 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.

Requirements

• 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.