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Senior Mechanical Design Engineer
Mount Kemble Search Group
- United States
- United States
Über
Senior Mechanical Design Engineer
with deep expertise in plastics and injection molding. This role will lead the design, development, verification, and validation of complex mechanical and electromechanical devices, with a strong focus on high-volume injection-molded components and assemblies. This is a highly visible, hands-on technical leadership position ideal for someone passionate about designing precision plastic components for regulated, high-performance applications. Key Responsibilities Lead end-to-end mechanical design of plastic components and assemblies, including housings, fluid paths, needle shields, dose mechanisms, and multi-component systems Serve as the subject matter expert in
injection molding , including material selection, tooling strategy, and process optimization Apply advanced knowledge in
insert molding, over-molding, and multi-shot molding techniques Perform and interpret
Moldflow (or equivalent) simulations
including fill, pack, cooling, warpage, and defect prediction Drive
Design for Manufacturability (DFM)
and
Design for Assembly (DFA)
from concept through production Conduct tolerance stack-ups and structural analysis for plastic components Partner with manufacturing teams to develop and validate processes, including
IQ/OQ/PQ activities Lead risk management efforts (ISO 14971), focusing on plastic materials, molding defects, and assembly risks Ensure compliance with applicable regulatory standards (ISO 13485, FDA 21 CFR Part 820, ISO 10993, ISO 11608) Provide mentorship and technical guidance to junior engineers and cross-functional teams Support continuous improvement initiatives for cost, quality, and efficiency Qualifications Required Bachelor’s degree in Mechanical Engineering, Plastics Engineering, or a related field (Master’s preferred) 10+ years of progressive experience in mechanical or product design Minimum 7+ years focused on
plastic component design and injection molding , ideally in medical device or regulated environments Strong hands-on experience with
Moldflow or similar simulation tools Demonstrated expertise in DFM/DFA for high-volume injection-molded components Experience with: Injection molding process development and troubleshooting Biocompatible and engineering-grade material selection Complex plastic assemblies with tight tolerances Knowledge of cGMP, FDA, and ISO standards (ISO 13485, ISO 14971, 21 CFR Part 820) Proven success leading validation activities (IQ/OQ/PQ) Proficiency with CAD tools (SolidWorks strongly preferred) Experience mentoring engineers or providing technical leadership Preferred Lean Manufacturing or Six Sigma certification (Green/Black Belt) Experience with DOE, scientific molding, and hot runner systems Prior work on drug delivery devices such as
autoinjectors, pen injectors, or combination products Work Environment 100% onsite role based in
Portsmouth, NH Frequent collaboration with manufacturing, quality, and R&D teams Hands-on involvement in both engineering design and production support Compensation & Benefits Base salary:
$150,000 annually , plus potential performance bonus Comprehensive medical, dental, and vision coverage –
100% employer-paid for employees and dependents 401(k) with company match Discretionary time off (DTO) + paid holidays Professional development support (training, conferences) Potential for equity/stock-based incentives
Sprachkenntnisse
- English
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