Engineer II, Process Development

JOB SUMMARY

The Engineer II, Process Development position is primarily responsible for designing, developing, and qualifying manufacturing processes, consisting of multiple engineering disciplines, for the manufacture of medical devices.

The position will be involved in the design, development, documentation, and validation and of new customer products, and modification of existing products, including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

ESSENTIAL RESPONSIBILITIES

• Attends and arranges project meetings to discuss current and future design and development initiatives.
• Serve as a primary contact with customers on programs of low to moderate complexity and serve as secondary contact with customers on programs of moderate to high complexity.
• Track and communicate the status of assigned action items that would affect timelines and budgets.
• Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
• Assist in the preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions.

Provide input to program management for tracking and communicating project status, plans, issues, timelines, action items, and budgets.

• Responsible for the following project inputs : Feasibility builds, documentation, root cause analysis, and testing, Equipment selection and qualification, Process development and documentation, Device Verification samples and testing, Operator training, Process Failure Mode Effects Analysis, Clinical builds, Process Validation.
• Involvement in the full design, development, and validation requirements of programs, including : Product design and specification creation, including mechanical and electrical components, assemblies, and packaging, Materials sourcing and device prototyping, Design verification and validation activities, including data for regulatory submission, Manufacturing transfer and support of existing product lines as applicable.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Complies with company, quality and safety standards, policies, and procedures
• Other duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• A bachelors degree (STEM engineer discipline preferred) and 2 years experience required : or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
• Willingness to travel, if required
• Must maintain high ethical standards
• Must demonstrate good organizational skills
• Must be able to read, write and speak fluent English
• Strong computer skills, including MS Office
• Experience with Minitab and statistical analysis
• Experience with documented change control processes.
• Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
• Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
• Ability to learn and apply new technology
• Technical report preparation and formal presentation skills

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority / Female / Individuals with Disabilities / Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law.

Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.