Associate Principal Engineer

About the role

Join Brasseler and be a valued team member of a world-class health care organization. Our Culture Provides a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected. Different perspectives are encouraged and lead to better results.

Responsibilities

• General Lead multidisciplinary technical teams and provides key engineering functions across multiple functional groups within the site
• Presents finished projects to site leadership
• Manages mid-scale projects
• Develops expertise in some areas of the dental and medical device industries
• Takes an active role in site-level decisions and initiatives
• Provides coaching/mentorship to other engineers
• Owns production and assembly operations
• Leads reviews of process design for compliance with engineering principles, company standards, customer contract requirements, and related specifications
• Designs and executes new process qualifications for new base technologies across multiple manufacturing platforms
• Researches future technologies to develop test methods that are accurate, time-efficient, and cost-effective
• Reviews and assesses the production "package"
• Designs and executes validation protocols (IQ, OQ, PQ) for the site for complex change programs to 21 CFR Part 11 compliance
• Leads the design and implementation of Application Programming Interfaces (APIs)
• Integrates multiple components from various sources into software applications
• Drafts high-level technical architecture with external partners
• Identifies inefficiencies in current system architectures and works to rebuild them
• Researches new technologies and software development practices
• Electro/Mechanical Perform the design and assembly of devices and equipment that blend electrical and mechanical components
• Supports and/or leads the development of equipment and devices at all stages, from concept creation to production tooling
• Aims to optimize safety, economy, reliability, sustainability, and quality
• Designs/builds small-scale control systems
• Generates accurate and controlled documents pertaining to process equipment
• Researches the latest technology and looks to implement in current equipment/processes

Requirements

• Bachelor’s or Masters Degree in Engineering (Mechanical, Chemical, Physics, Computer sciences)
• Ability to define documents such as operating and maintenance instructions, technical drawings, industrial standards and procedure manuals
• Ability to write technical reports and technical correspondence with management
• Ability to review and critique junior engineers reports
• Detail oriented, and ability to organize, document and communicate across the organization
• 5+ years Medical or dental device manufacturing working experience
• Advanced Knowledge of regulatory requirements (FDA and others)
• High level of proficient in GMP quality standards
• Experience of executing Six Sigma and Lean Manufacturing projects and deployment and training of these concepts
• Experience leading large scale projects in a manufacturing environment
• The ability to manage project cost and keep within defined budget
• Experience in research projects and product conceptualization

Skills

• Excellent understanding of industry practices
• Strong proficiency with tools, systems, and procedures
• Strong planning/organizational skills and techniques
• Strong decision making, analysis and problem-solving skills with ability to multi-task
• Excellent verbal and written communication skills
• Strong presentation and public speaking skills
• Strong interpersonal skills
• Strong conflict resolution skills and ability to deliver difficult messages
• Ability to build partnerships at all levels within the company, ability to build partnerships externally
• Good negotiating skills
• Resolve complex issues in effective ways
• Project management, consultative skills and ability to manage a budget

Qualifications

• Typically 6 to 8 or more years of increasing responsibility in terms of any applicable professional experience
• Typically a Bachelor's Degree or global equivalent in related discipline
• Master's degree or global equivalent a plus
• May hold one or more industry certifications

Benefits

Benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities. Benefits may vary by location or status.

Pay

Commensurate with experience

Schedule

N/A