Senior Engineering Manager

Aspen Surgical; Caledonia (MI); On-site; USD 140,000 - 170,000; Full time

Job summary

Aspen Surgical in Michigan seeks a Senior Engineering Manager to build, lead, and develop an engineering department spanning Manufacturing/Mechanical, Injection Molding, Controls/Automation, and Project Management. You will drive strategic projects, ensure compliance with FDA/ISO requirements, manage budgets, and mentor a high-performing team to deliver safe, high-quality medical devices.

A strong communicator with a coaching mindset and proven ability to align engineering work with customer

Qualifications

• BS in Mechanical Engineering required; 10 years of manufacturing experience.
• Minimum 3–5 years leadership in Engineering.
• Experience with medical devices and FDA/ISO requirements is a plus.
• Strong project management and communication skills.
• Ability to connect engineering work to customer impact and business goals.

Responsibilities

• Build and develop engineering team capabilities across Manufacturing/Mechanical, Injection Molding, Controls/Automation, and Project Management.
• Prioritize strategic projects impacting Safety, Quality, Delivery, Cost, Morale, and Environment.
• Own team outcomes, set goals, remove blockers, and ensure high-quality results.
• Improve the Engineering Quality System to comply with regulatory requirements.
• Oversee CapEx planning and investment decisions.
• Represent engineering in regulatory audits (FDA, Notified Body).
• Foster collaboration and a positive, solution-focused culture.
• Negotiate with internal customers to resolve priorities.
• Report project status to Aspen Leadership Team.
• Ensure designs meet product requirements and address post-launch issues.

Skills

Project management

Leadership

Regulatory compliance

Cross-functional collaboration

Communication

Coaching

Talent development

FDA/ISO knowledge

Risk assessment

VOC

Stage-gate

Education

Bachelor of Science in Mechanical Engineering

Job description

About Aspen Surgical We love what we do. At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This dedication drives an industry-leading standard and makes a real and lasting impact on people’s lives around the world. We strive to provide the tools, resources, and support needed to set our team members up for success.

Summary

The Senior Engineering Manager is responsible for building, leading, and developing a high-performing engineering department spanning multiple disciplines including Manufacturing/Mechanical Engineering, Injection Molding, Controls/Automation, and Project Management.

Responsibilities

• 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 timely, high-quality results.
• Recommend and implement solutions to improve the engineering Quality System in compliance with regulatory requirements.
• Recommend capital investment where applicable and manage forward-looking CapEx requirements.
• Audit and improve run rate standards and represent engineering in regulatory audits (FDA, Notified Body, etc.).
• Foster a culture of positivity, teamwork, solution delivery, and collaboration.
• Negotiate with internal business customers to resolve priority issues.
• Report regularly to Aspen Leadership Team on project status.
• Provide oversight to ensure designs meet product requirements and remediate design and component problems after product launch.
• Ensure a safe work environment by designing for safe manufacturability and customer use.
• Participate in Risk Assessments and FMEAs to ensure customer specifications and design intents are met.
• Manage remediation needs to ensure product files remain compliant with regulations.

Qualifications

• Bachelor of Science degree in Mechanical Engineering required with 10 years of relevant manufacturing experience.
• Minimum of 3–5 years leadership in Engineering required.
• Medical Device or related industry experience including FDA and ISO requirements is a plus.
• Strong project management capabilities to drive on-time schedule adherence and effective 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 provide constructive feedback and foster professional growth 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 a commitment to ethics and conduct.
• Experience managing in a matrix organization with high production volume medical device disposables.
• Familiarity with customer needs analysis methodologies such as VOC.
• Experience with requirements management (Design Input/Output) and phased product development processes, stage-gate project management, etc.
• Ability to develop effective working relationships with cross-functional personnel, internally and externally.

Physical Requirements

Note: The inability to perform any listed physical requirements does not preclude consideration unless it is an essential job function that cannot be accommodated.

Please refer to the essential duties and responsibilities for details.

We are proud to be an equal opportunity employer and celebrate our employees’ differences regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Diversity makes us better.