The Engineer II, Process Development will be responsible for designing, developing, and qualifying manufacturing processes for medical devices, leveraging expertise across multiple engineering disciplines. The role encompasses involvement in all stages of product development, including design, prototyping, documentation, validation, and manufacturing transfer. The Engineer II will focus on developing processes for new products, improving existing processes, and ensuring compliance with medical device quality regulations. This is an on-site position.

Key Responsibilities:

Project Leadership & Communication:

Attend and coordinate project meetings, serving as the primary contact for customers on low to moderate complexity projects, and as a secondary contact for more complex projects.

Track project status, timelines, and budgets while ensuring timely communication of updates and resolution of questions.

Proposal & Quotation Support:

Assist in the preparation of proposals and quotations, working closely with clients to clarify technical requirements and ensure accurate documentation.

Project Planning & Execution:

Contribute to the creation and maintenance of project plans, ensuring alignment with key milestones, deadlines, and budgets. Collaborate with program management to track and communicate project status, issues, and action items.

Process Development:

Lead process-related initiatives including feasibility builds, equipment selection and qualification, process documentation, device verification testing, operator training, clinical builds, and process validation.

Design & Validation:

Engage in full product lifecycle activities, including product design, material sourcing, prototyping, design verification and validation, and regulatory submission support. Assist in the transfer of products to manufacturing and provide ongoing support for existing product lines.

Quality Assurance:

Ensure compliance with medical device quality regulations throughout development and process transfer phases. Conduct root cause analysis and testing to resolve process-related issues.

Operator Training & Documentation:

Train operators on new processes and ensure that all process documentation is accurate and up-to-date.

Contribute to Process Failure Mode Effects Analysis (PFMEA) and other risk assessments.

Reliability & Compliance:

Demonstrate consistent, reliable, and punctual attendance. Comply with company policies, quality, and safety standards.

Other Duties:

Perform other duties as required based on the needs of the business.

Qualifications:

Education & Experience:

Bachelors degree in a STEM engineering discipline (preferred)

Minimum of 2 years of relevant engineering experience, preferably in the medical device industry

Experience with mechanical, tool design, and manufacturing processes

Technical Skills:

Proficiency in MS Office, including Word, Excel, and PowerPoint

Experience with Minitab and statistical analysis

Strong ability to interpret technical drawings, blueprints, and specifications

Familiarity with documented change control processes and technical reporting

Communication & Organizational Skills:

Excellent verbal and written communication skills in English

Strong organizational skills, with attention to detail and ability to manage multiple tasks

Ability to prepare technical reports and deliver formal presentations

Analytical Skills & Problem-Solving:

Strong analytical skills, with the ability to gather and evaluate secondary research information

Ability to apply new technologies and problem-solving techniques to engineering challenges

Ethics & Standards:

High ethical standards and commitment to quality and safety

Willingness to travel if required

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

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