SummaryThe Senior Engineering Manager is responsible for building, leading, and developing a high-performing engineering department spanning multiple disciplines:
- Manufacturing/Mechanical Engineering
- Injection Molding
- Controls / Automation
- Project Management
In This Position, You Will Have the Opportunity To- Build and Develop Engineering team capabilities to align with company objectives.
- Recommend and prioritize strategic projects that impact Safety, Quality, Delivery, Cost, Morale, and the Environment.
- Drive accountability by owning engineering team outcomes, setting realistic goals, removing blockers, and ensuring the team delivers, quality on time results.
- Recommend and implement creative solutions to improve engineering Quality System in compliance with regulatory requirements.
- Recommend Capital investment where applicable and manage forward looking CapEx requirements.
- Responsible for auditing and improving run rate standards
- Represent engineering functions for regulatory audits (FDA, Notified body, etc).
- Further develop and grow a culture of positivity, teamwork, solution delivery and collaboration.
- Negotiate directly with the internal business customers to resolve priority issues.
- Report regularly to Aspen Leadership Team on status of projects.
- Provide oversight to ensure designs meet the product requirements and to remediate design and component problems that are discovered after product launch.
- Provide a safe work environment by ensuring that products are designed for safe manufacturability, as well as usage by customers.
- Participate in Risk Assessments and FMEA's to ensure customer specifications and design intents are adhered to.
- Manage remediation needs of the business to assure that product files are compliant to the regulations.
What You Need to Succeed in This Position- Bachelor of Science degree in Mechanical Engineering required with 10 yrs. of relevant manufacturing experience
- Minimum of 3 - 5 years leadership in Engineering required.
- Medical Device or related industry experience that includes FDA and ISO requirements is a plus
- Strong project management capabilities to drive on time schedule adherence and communication.
- Demonstrated business acumen, with the ability to connect engineering work to customer impact, organizational priorities, and measurable outcomes.
- Excellent communication skills with the ability to explain priorities clearly, listen well, and adapt the message for engineers, executives, and cross-functional partners
- Coaching mindset, with the ability to deliver constructive feedback and foster professional growth and development within the team.
- Proven ability to attract, develop, and retain top engineering talent to meet evolving business needs.
- Thorough understanding and consistent application of company policies, procedures, programs, and regulatory requirements, with an unwavering commitment to the Corporate Code of Ethics and Standards of Conduct.
- Experience managing in a matrix organization working with high production volume medical device disposables.
- Familiarity with customer needs analysis methodologies such as VOC
- Experience with requirements, and requirements management (i.e. Design Input / Output)
- Proficiency with phased product development processes, stage-gate project management, etc.
- Demonstrated ability to develop effective working relationships with cross functional personnel, both internally and externally.
Physical Requirements:
NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities.
